Current Issue : April-June Volume : 2013 Issue Number : 2 Articles : 164 Articles
A simple, selective, rapid, precise and economical reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Tramadol hydrochloride and Diclofenac sodium from pharmaceutical formulation. The method was carried out on a C18 (25 cm x 4.6 mm i.d., 5 μ) column with a mobile phase consisting of Methanol: water (adjusted to pH 3.0 using orthophosphoric acid) in the ratio of 80:20 v/v with 0.25% (v/v) triethyl amine (TEA).The retention time of Tramadol hydrochloride and Diclofenac sodium was 3.2min and 6.1min respectively with the flow rate of 1 mL. min-1. Eluents were detected at 273 nm. The linear regression analysis data for the linearity plot showed good linear relationship with correlation coefficient value for Tramadol hydrochloride and Diclofenac sodium were R2 = 0.9997 and R2 = 0.9999 in the concentration range of 5-50 µg. mL-1 , 10-70 µg. mL-1 respectively. The relative standard deviation for intra-day precision was lower than 2.0%. The method was validated according to the ICH guidelines. The method was also found to be robust. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms....
Mycotoxins are secondary metabolites of filamentous fungi. They pose a health risk to humans and animals due to their harmful biological properties and common occurrence in food and feed. Mycotoxins contamination of food and feedstuffs is among the top priorities for human and animal safety. Analytical methods for mycotoxins in cereals and cereal-based products require three major steps, including extraction, clean-up (to eliminate interferences from the extract and concentrate the analyte), and detection / determination of the toxin (by using suitable analytical instrument s/technologies). Clean-up is essential for the analysis of mycotoxins at trace levels, and involves the use of solid phase extraction and multifunctional or immunoaffinity columns. The currently used techniques for mycotoxin determination, either chromatography or ELISA. Different chromatographic methods are commonly used for quantitative determination of mycotoxins, including gas-chromatography (GC) coupled with electron capture, flame ionization or mass spectrometry (MS) detectors and high-performance liquid chromatography (HPLC) coupled with ultraviolet, diode array, fluorescence or MS detectors. The choice of method depends on the matrix and the mycotoxin to be analyzed. Liquid chromatography-tandem mass spectrometry (LC MS/MS) is spreading rapidly as a promising technique for simultaneous screening, identification and quantitative determination of a large number of mycotoxins. In addition, commercial immunometric assays, such as enzyme-linked immunosorbent assays (ELISA), are frequently used for screening purposes as well. Recently, a variety of emerging methods have been proposed for the analysis of mycotoxins in cereals based on novel technologies, including immunochromatography, fluorescence polarization immunoassays (FPIA), infrared spectroscopy (FT-NIR) and molecularly imprinted polymers (MIPs). This review deals with the current analytical methodologies (traditional and emerging), available for the detection of main mycotoxins occurring in cereals and cereal-based products....
A simple, sensitive and cost effective visible spectrophotometric method has been developed for the determination of Diacerein in capsule dosage form. The method is based on the formation of pink colored chromogen upon dissolving the drug in sodium bicarbonate solution with an absorption maximum of 442 nm. The Beer’s law was obeyed in the concentration range of 0.1 – 160 µg/ml. The proposed method was successfully applied for the estimation of Diacerein in commercially available capsules and the results were statistically calculated and validated. The method was found to be accurate with average percentage recovery of 98.4-99.6. Solution of Diacerein was found to be stable for 2 days under room temperature. The method was found to be rugged and robust....
To develop UV spectrophotometric method for the estimation of Paracetamol, Domperidone and Flunarizine in the combined tablet dosage form available in the market for the treatment of migraine. The three drugs Paracetamol, Domperidone, and Flunarizine are present in the ratio of 100:2:1 which poses a problem in their simultaneous estimation. Hence, an effective and reproducible extraction method to extract out Paracetamol from the combination was developed and applied successfully to the formulation. The estimation of Paracetamol was done at 256 nm. The two drugs Domperidone and Flunarizine were simultaneously estimated by first order derivative method. Wavelengths 223.97nm (ZCP for Flunarizine) and 256.30 nm (ZCP for Domperidone) were selected for the estimation of Domperidone and Flunarizine from their overlain first order derivative spectra. The concentration of the three drugs was determined by the proposed method. The method was validated as per the ICH guidelines. Linearity was observed in concentration range of 4-12 µg/ml for Paracetamol and 10-40 µg/ml for both drugs Domperidone and Flunarizine. The accuracy of the method was evaluated by recovery studies and good recovery results were obtained between 97 % to 100 % and the relative standard deviation was found to be below 2 %. A simple, accurate, precise and economical UV-spectrophotometric method for the estimation of Paracetamol, Domperidone, and Flunarizine in combined dosage form has been developed, which can be applied for their routine analysis....
The study describes a validated reverse-phase HPLC method for the simultaneous estimation of Meropenem and Sulbactam in combined dosage form. The proposed RP-HPLC method utilizes Hiber C18 column (250 × 4.6 mm i.d., 5 μm), optimum mobile phase consisted of gradient run of initial ratio of Sodium phosphate dibasic (pH-5.0 adjusted with orthophosphoric acid): Acetonitrile (90:10) with the effluent flow rate of 1.0 ml/min, and UV detection wavelength 230 nm. The developed method was statistically validated for linearity, precision, recovery and ruggedness. The method was linear over the range of 50-150 μg/ml for Meropenem and 25-75 μg/ml for Sulbactam. The mean recovery was 100.06% and 100.29% for Meropenem and Sulbactam respectively. The intermediate precision data obtained under different experimental setup was quite concurrent with less critical % RSD. The proposed method can be useful in the quality control of Meropenem and Sulbactam in bulk drug and drug products....
A simple, rapid reverse phase high performance liquid chromatographic method (RP-HPLC) has been developed and validated for simultaneous estimation of Drospirenone and Ethinylestradiol in tablet dosage form. Chromatographic separation was carried out on Shimadzu HPLC (LC-20AT) using C-18 (250 mm × 4.6 mm, 5.0 μ) as stationary phase and mobile phase containing Acetonitrile:Water (60:40 v/v) at flow rate of 1 ml/min using UV detection at 225 nm. The retention time for Ethinylestradiol and Drospirenone was found to be 5.69 and 6.79 min respectively. The method was validated as per ICH guideline and successfully used for the quantitative analysis of commercially available tablet. The calibration curve was linear over the concentration range of 5-15 µg/ml for Ethinylestradiol and 50-150 µg/ml for Drospirenone. Limit of detection and Limit of quantitation was found to be 0.585 µg/ml and 1.772µg/ml for Drospirenone and 0.057 µg/ml and 0.174 µg/ml for Ethinylestradiol respectively. The % RSD below 2.0 shows the high precision of proposed method....
The aim of this work was to develop and validate a dissolution test for ILAPRAZOLE in Tablets using spectrophotometric method. The dissolution established conditions were 0.1N HCL 900 mL for 2 hrs then transfer 900 ml of phosphate buffer pH 7.5 with 0.1% of sodium lauryl sulphate as dissolution medium, using a paddel apparatus at a rotating rate of 100 rpm. The drug release was evaluated by UV spectrophotometric method at 308 nm. The method was validated to meet requirements for a global regulatory filing. The validation included specificity, linearity, precision and accuracy....
A new simple, sensitive, precise and accurate high-performance liquid chromatography (HPLC) method of analysis for Artemether both as a bulk drug and in capsule formulations was developed and validated. The method employed mobile phase acetonitrile and phosphate buffer in the ratio 60:40 of pH 3 ±0.5. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9996 in the concentration range 20-100 µg/ml. The mean value slope and intercept were 124557 and 118672 respectively. The method was validated for precision, accuracy and recovery studies. Limit of detection (LOD) and Limit of quantitation (LOQ) for Artemether were found to be 0.00045 x 10-05, 0.00013 x 10-03 respectively. The method has been successfully applied in the analysis of marketed formulations....
A new, rapid, sensitive, simple and cost effective UV spectroscopic method was developed for the estimation of Carvedilol in bulk and pharmaceutical dosage form. The relative intensity of Carvedilol was measured in triple dissolution media at wavelength of 240 nm. Linearity range was found to be 20 to 200 µg/ml. The method validated for various parameter as per the ICH guidelines and USP requirements. The detection and quantization limits were found to be 2.84 & 8.62 µg/ml respectively. The results demonstrate that the procedure is accurate, precise and reproducible, while being simple and rapid too. The results were found to be in good agreement with the label claims....
Lapatinib is an orally active drug for breast cancer and other solid tumours. It is used in combination therapy for HER-2 positive breast cancer. A simple and precise calorimetric method was developed for determination of Lapatinib in pharmaceutical dosage forms using MBTH reagent. Lapatinib exhibit λ max at 661 nm in solvent methanol and obeyed linearity in concentration range 2-10 µg/ml. The colorimetric reagent used is MBTH and the oxidising agent used is ferric chloride. The LOQ and LOD are found to be 0.36 and 0.121 mcg/ml respectively. The method is statistically validated....
A simple, specific, accurate and precise colorimetric method has been developed and validated for the determination of Tacrolimus (TCR) in bulk and its capsule dosage form. The proposed method involves the chemical derivatization of the drug with 2, 4-dinitrophenylhydrazine (2, 4-DNP) in the presence of an acid catalyst, followed by treatment with methanolic solution of potassium hydroxide; an intensely colored compound was formed that was measured in methanol as the diluting solvent at 439 nm. All variables affecting the development of the measured colored compound were studied and optimized. Beer's law was obeyed in the concentration ranges of 50-175 µg/ml with acceptable correlation coefficient of 0.9910. The limit of detection (LOD) and limit of quantification (LOQ) for this method were found to be 5.0051 and 15.1671 µg/ml respectively. The % relative standard deviations for intra-day and inter-day precision studies were found to be less than 2%. The % recovery of TCR was found to be 98.51-100.49% confirming accuracy of the method. The proposed method was applied successfully for the determination of TCR in bulk and in its capsule dosage form without interference of any matrix additives proving its specificity....
Today synthetic indicators are the choice of acid-base titrations but due to environmental pollution, availability and cost, the search for natural compounds as an acid-base indicator was started. Indicators help to determine the equivalence point in acid – base titrations (neutralization titrations). They show sharp color change with respect to change in pH. Commonly used indicators for neutralization titrations are synthetic in nature. The highly colored pigments obtained from plants are found to exhibit color changes with variation of pH. This study has been done to investigate the acid base indicator activity of hydro-alcoholic extract of Dahlia pinnata’s flower pigments and compared with already existing synthetic indicators....
Fenofibrate in conjunction with rosuvastatin calcium is used in in the treatment of hypercholesterolemia and hypertriglyceridemia. A simple, accurate, precise and cost effective first order derivative UV spectrophotometric method has been developed for determination of Rosuvastatin calcium (ROS) and Fenofibrate (FEN) in tablet dosage form. The Beer-Lambert‘s law was obeyed in the concentration range 4-12 µg/ml and 16-48 µg/ml for ROS and FEN, respectively. The proposed method was validated and successfully applied to the determination of ROS and FEN in tablet formulations. The results suggested that proposed method can be used for routine quality control of tablets containing ROS and FEN....
A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of clopidogrel bisulphate in tablet. The chromatographic separation was carried out on an Inertial BDS C18 250 x 4.6 x 5 mm column with a mixture of Methanol: Water (70:30) as mobile phase; at a flow rate of 1 ml/min. UV detection was performed at 222 nm. The retention times of clopidogrel bisulphate are 3.45. Calibration plots were linear (r 2>0.994) over the concentration range 2-10 μg/ml for clopidogrel bisulphate. The method was validated for accuracy, precision, linearity, and LOD & LOQ. The proposed method was successfully used for quantitative analysis of tablet. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of clopidogrel bisulphate in bulk drug and tablet dosage form....
Simple, accurate, rapid, economical spectroscopic methods namely Zero order have been developed and validated for estimation of Pentoxifylline in tablet dosage form using distilled water as a solvent according to ICH Guidelines Q2R1. Absorbance of each solution was measured at 271.8 nm for zero order spectrophotometry. Pentoxifylline show linearity over the range of 5-25 μg/ml for the developed method. Therefore, the proposed method can be applied for routine analysis of Pentoxifylline in tablet dosage forms....
A novel combination of Acebrophylline and Montelukast Sodium is used in the treatment of chronic obstructive pulmonary disease (COPD) and bronchial asthma. A novel Reversed-phase high-performance liquid chromatographic method for the simultaneous determination of Acebrophylline and Montelukast sodium was developed and validated. A reversed phase high-performance liquid chromatographic analysis was performed on Unisphere C18 column (250 mm X 4.6 mm i.d., 5 µm particle size) at 40°C; the mobile phase, consisting of a mixture of Sodium acetate (200 mM, pH adjusted to 6 with glacial acetic acid): Methanol: Acetonitrile (20:30:50 v/v/v) was delivered at a flow rate of 1.0 mL/min and detector wavelength at 272 nm. The retention time of Theophylline-7-acetate and Ambroxol was found to be 2.22 and 4.52 min respectively as an individual component of Acebrophylline and 5.22 min for Montelukast sodium. Linearity ranges were 100-600 and 5-30 µg/ ml with limit of detection values of 0.52 and 0.05µg/ml for Acebrophylline and Montelukast sodium respectively In First order derivative spectroscopy method, absorbance of Acebrophylline was measured at 282 nm (Zero Crossing Point of Montelukast sodium) and absorbance of Montelukast sodium was measured at 368 nm (Zero Crossing Point of Acebrophylline). The drugs obeyed the Beer’s law in the concentration range of 20-140 µg/ml for Acebrophylline and 1-7 µg/ml for Montelukast sodium. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. Correlation coefficients (r2) of the regression equations were greater than 0.999 in all cases. According to the validation results, the proposed methods were found to be specific, accurate, and precise and could be applied to the simultaneous quantitative analysis of Acebrophylline and Montelukast sodium in pharmaceutical formulation....
The aim of the present work is to develop simple accurate, precise and cost effective UV-Vis spectrophotometric method for the estimation of pamabrom in bulk and tablet dosage form determination of percent degradation by using different stress condition. Pamabrom shows the maximum absorbance (λmax) at 279 nm in distilled water and was utilized for its determination. Drug was found to follow the Beer-Lambert’s law in the concentration range of 2-20 μg/ml. The suggested method is validated by using ICH validation parameters like accuracy, precision, linearity, LOD and LOQ respectively. Standard deviation and RSD for intra-day and inter-day precision studies was found to be less than ± 2. The limit of detection and limit of quantification was found to be 0.239 μg/ml & 0.725 μg/ml. The proposed method was successfully applied to the determination of pamabrom in pharmaceutical formulations without any interference from excipients. Results of the analysis were validated statistically and found to be satisfactory. Pamabrom was subjected to stress degradation under different conditions recommended by ICH. The samples generated were used for degradation studies using the developed method....
A simple, specific, accurate and stability-indicating UV- Spectrophotometric method was developed for the estimation of ilaprazole, using a Shimadzu, model 1800 spectrophotometer and as a solvent methanol used at wave length (λmax) 306 nm. Linearity was established for ilaprazole in the range of 2-10 μg/ml. The percentage recovery of was found to be in the range of 99.22-100.21 %. The drug was subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, UV light and photolytic degradation. The proposed method for stability study shows that there was appreciable degradation found in stress condition of ilaprazole....
A simple, efficient, and reproducible RP-HPLC method for the simultaneous determination of Cefixime trihydrat and Moxifloxacin HCl in pharmaceutical formulations has been developed and validated. The separation was carried out on Hyperchrom ODS-BP (4.6 mm X 200 mm, 5 μm) column using acetonitrile: 0.05 M potassium dihydrogenortho phosphate (adjusted to pH 4 with 10% OPA) in the ratio of 50:50 v/v as eluent. The flow rate was 1 ml/min and effluent was detected at 279 nm. The retention time of Cefixime and Moxifloxacin were 4.937 and 3.963 min. respectively. The linear dynamic range was 25-75 μg/ml for Cefixime and Moxifloxacin, respectively. Percentage recoveries for Cefixime and Moxifloxacin were 99.85-100.16% and 99.68-100.50% respectively. All the anal validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of Cefixime and Moxifloxacin in tablet dosage forms....
A new, simple, rapid, accurate, sensitive and precise Q-Absorption Ratio Spectrophotometric method was developed and validated for the simultaneous estimation of Vardenafil and Dapoxetine Hydrochloride in combined tablet dosage form. The measurement of absorbance was performed at 276.0 nm (iso-absorptive point) and 292.0 nm (Absorption maxima of Dapoxetine Hydrochloride). Beer's law was obeyed over a concentration range of 7.5-30 μg/ml for Vardenafil (r2=0.9992) and 15-60 μg/ml for Dapoxetine Hydrochloride (r2=1.0000). The relative standard deviation was found to be <2.0%. The LOD for Vardenafil and Dapoxetine HCl were found to be 0.53 μg/ml and 0.675 μg/ml respectively. LOQ for Vardenafil and Dapoxetine HCl were found to be 1.59 μg/ml and 2.05 μg/ml respectively. The method showed good recovery for both the drugs indicating its accuracy. The method was validated according to ICH guidelines. A marketed tablet formulation was analysed by the developed method. The developed Q-ratio method can be successfully applied for routine analysis of Vardenafil and Dapoxetine Hydrochloride in bulk and combined dosage form without any interference of the excipients....
Epalrestat and Methylcobalamin are the fixed drug combination approved by the CDSCO for the treatment of Diabetic Neuropathy. A simple and sensitive spectrophotometric method has been developed for Epalrestat and Methylcobalamin in a combined pharmaceutical dosage form. Linearity range was observed in the concentration range of 5-25 μg/ml for Epalrestat and 10-50 μg/ml for Methylcobalamin. The method involved Q-absorption analysis based on the measurement of absorbance at two wavelengths, i.e. λmax of Methylcobalamin (351.50 nm) and Iso-absorptive point of both drugs (267.50 nm). The method was validated statistically and recovery study was performed to confirm the accuracy of the method. The method was found to be rapid, simple, accurate and precise....
A simple and sensitive spectrophotometric method has been developed for simultaneous determination of Tolperisone hydrochloride and Diclofenac sodium in a combined pharmaceutical dosage form. In the proposed method, the absorbances were measured at 261.0 nm and 276.0 nm corresponding to the absorbance maxima of Tolperisone hydrochloride and Diclofenac sodium in Dist. Water respectively. Linearity range was observed in the concentration range of 4-24 μg/ml for Tolperisone hydrochloride and 5-30 μg/ml for Diclofenac sodium. Concentration of each drug was obtained by using the absorptivity values calculated for both drugs at two wavelengths, 261.0 nm and 276.0 nm and solving the simultaneous equation. Developed method was applied to pharmaceutical formulation. The method was validated statistically and recovery study was performed to confirm the accuracy of the method. The method was found to be rapid, simple, accurate and precise....
An accurate, precise and ecofriendly spectrophotometric method is presented for the determination of Cefixime based on the formation of a yellow colour product with ninhydrin in the presence of bicarbonate with an absorption maximum at 438 nm. The reaction proceeds quantitatively at 97±1°C in 15 min. The calibration curve is linear over the range of 45-65 μg/ml and is described by the regression equation A=(-) 0.858+0.021 C with a regression coefficient (r) of 0.9987 (n=5). The calculated molar absorptivity and Sandell sensitivity values are 4.1536 x 103 L/mol/cm and 0.0072 μg/cm2, respectively. The limits of detection (LOD) and quantification (LOQ) calculated as per ICH guidelines are 1.13 and 3.40 μg/ml, respectively. The within-day accuracy expressed as relative error was better than 2.5% with precision (RSD) ranging from 1.02 to 1.93%. The between-day accuracy ranged from 1.5-3.0% with a precision less than 4%. Accuracy was also checked by placebo blank and synthetic mixture analyses besides a recovery study via standard addition procedure....
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical colorimetric method for the determination of tolperisone hydrochloride (TOL) in bulk and tablet dosage form. In this study a colorimetric method was used for determination of tolperisone hydrochloride by forming a colored chromogen. The measurements were carried out at wavelengths of 551 nm. The method was found to be linear (r2>0.991) in the range of 10-40 μg/ml for tolperisone hydrochloride. The limit of determination was 0.81 μg/ml and limit of quantification was 2.46 μg/ml for tolperisone hydrochloride. The method was successfully applied for simultaneous determination of tolperisone hydrochloride in tablet dosage form....
The use of first order derivative spectrophotometry allows simultaneous determination of Pantoprazole and Domperidone in fixed dose combination products. The wavelengths 287 nm and 289.99 nm of first derivative spectrum were selected for the estimation of pantoprazole and domperidone, respectively without mutual interference. The method was linear in the concentration range 8-40 μg/ml and 2-10 μg/ml for pantoprazole and domperidone, respectively. The method was validated in terms of accuracy and precision. The result of the formulation analysis shows that the proposed method can be successfully used for the simultaneous estimation of both the drugs in their combined dosage form....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Diclofenac sodium and Chlorzoxazone by employing first order derivative zero crossing method in 0.1 N NaOH. The first order derivative absorption at 288 nm (zero cross point of Chlorzoxazone) was used for quantification of Diclofenac sodium and 273.6 nm (zero cross point of Diclofenac sodium) for quantification of Chlorzoxazone. The linearity was established over the concentration range of 1.2-3.6 µg/ml and 12-36 µg/ml for Diclofenac sodium and Chlorzoxazone with correlation coefficient r 2 0.9993 and 0.9977, respectively. The mean % recoveries were found to be in the range of 98.88–102% and 99.11–101% for Diclofenac sodium and Chlorzoxazone respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of Diclofenac sodium and Chlorzoxazone in their synthetic mixture....
A simple, accurate, precise and sensitive First order derivative Spectrophotometric method was developed for the estimation of Clomiphene Citrate in bulk and pharmaceutical dosage forms. The estimation of Clomiphene Citrate was carried out at maximum absorbance of 293 nm. The method was found to be linear and obeys Beer’s law in the concentration range of 10-50 mcg/ml. The developed method was validated according to ICH guidelines and was found to be accurate and precise. Thus the proposed method can be successfully applied for the estimation of Clomiphene Citrate in bulk and pharmaceutical dosage forms....
A Simple, accurate, precise and sensitive first order derivative spectrophotometric method was developed and validated for the determination of cefixime trihydrate and dicloxacillin sodium in combine tablet dosage forms. First order derivative spectrophotometric method is adopted to eliminate spectral interference. Cefixime trihydrate and dicloxacillin sodium have λmax at 283 nm and 276 nm respectively in methanol solvent. The method was found to be linear and obeys beer’s law in concentration range of 12-32 µg/ml for both cefixime trihydrate and dicloxacillin sodium. The developed method was validated as per ICH guidelines....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Cefixime (CEF) and Levofloxacin (LEVO) by employing first order derivative zero crossing method in Methanol. The first order derivative absorption at 290 nm (zero cross point of Cefixime) was used for quantification of Levofloxacin and 265 nm (zero cross point of Levofloxacin) for quantification of Cefixime. The linearity was established over the concentration range of 4-20 µg/ml and 2.5-10.5 µg/ml for Cefixime and Levofloxacin with correlation coefficient r2 0.9984 and 0.9996, respectively. The mean % recoveries were found to be in the range of 98.60% –101.19% and 98.04%–101.66% for Cefixime and Levofloxacin, respectively. The proposed method has been validated as per ICH guideline and successfully applied to the estimation of Cefixime and Levofloxacin in bulk and in market formulation....
A simple, accurate, precise and sensitive first order derivative spectrophotometric method was developed and validated for the determination of cefixime trihydrate and linezolid in combine tablet dosage forms. First order derivative spectrophotometric method is adopted to eliminate spectral interference. Cefixime trihydrate showed zero crossing points at 235.6 nm and 266.09 nm and 287.15 nm, while Linezolid showed zero crossing points at 223.8 nm and 251 nm. The method was found to be linear and obeys beer’s law in concentration range of 4-12 µg/ml for cefixime trihydrate and 12-36 µg/ml for linezolid. The developed method was validated as per ICH guidelines. The relative standard deviation (RSD) for repeatability, intraday and interday was found to be less than 2 %. This method is found suitable for day to day analysis of cefixime trihydrate and linezolid in combined tablet dosage form....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Cefpodoxime proxetil (CPD) and Levofloxacin hemihydrate (LVX) by employing first order derivative zero crossing method in methanol. The first order derivative absorption at 235 nm (zero crossing point of Cefpodoxime proxetil) was used for quantification of Levofloxacin hemihydrate and 265 nm (zero crossing point of Levofloxacin hemihydrate) for quantification of Cefpodoxime proxetil. The linearity was established over the concentration range of 2-10 µg/ml and 2.5-10.5 µg/ml for Cefpodoxime proxetil (r2= 0.9985) and Levofloxacin hemihydrates (r2=0.9994) respectively. The mean % recoveries were found to be in the range of 99.30 % – 100.73 % and 99.67 % – 100.57 % for Cefpodoxime proxetil and Levofloxacin hemihydrate respectively. The proposed method has been validated as per ICH guideline and successfully applied to the estimation of Cefpodoxime proxetil and Levofloxacin hemihydrate in bulk drug and pharmaceutical dosage form....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Ceftazidime (CTZ) and Clavulanic acid (CA) by employing first order derivative zero crossing method in dist.water. The first order derivative absorption at 256 nm (zero cross point of Ceftazidime) was used for quantification of Clavulanic acid and 278 nm (zero cross point of Clavulanic acid) for quantification of Ceftazidime. The linearity was established over the concentration range of 4-20 µg/ml and 50-250 µg/ml for Ceftazidime and Clavulanic acid with correlation coefficient r2 0.9974 and 0.9979, respectively. The mean % recoveries were found to be in the range of 99.63%–99.88% and 99.96%–100.29% for Ceftazidime and Clavulanic acid, respectively. The proposed method has been validated as per ICH guideline and successfully applied to the estimation of pharmaceutical dosage form....
First order derivative spectroscopy method involves the measurement of absorbance at zero crossing point of other drug. A new, rapid, precise, accurate and sensitive first derivative spectrophotometric method is proposed for the simultaneous estimation of Citicoline and Methylcobalamin in pharmaceutical dosage form. The drugs obeyed the Beer’s law in the concentration range of 10-20 ug/ml (r2 = 0.999) for Citicoline and 15-30 ug/ml (r2 = 0.999) for Methylcobalamin. In the proposed method, absorbance was measured at 267.86 nm (Zero Crossing Point of Metylcobalamin) for Citicoline and 270.89 nm (Zero Crossing Point of Citicoline) for Methylcobalamin. Accuracy of the method was determined by recovery studies and the average % recovery was found to be 99.97% and 99.92% for Citicoline and Methylcobalamin respectively. The LOD for Citicoline and Methylcobalamin were found to be 1.9041 μg/ml and 1.5617 μg/ml and LOQ were found to be 1.077 μg/ml and 1.07325 μg/ml respectively. Statistical analysis proves that the method is selective and sensitive for estimation of Citicoline and Methylcobalamin in pharmaceutical dosage form. The results were found to be within acceptance criteria according to ICH Q2 R1 guideline....
The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of Diclofenac Potassium and Febuxostat in combined tablet dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectrum was obtained in 0.1 N NaOH and the determinations were made at 282.12 nm (ZCP of Febuxostat) for Diclofenac Potassium and 255.17 nm (ZCP of Diclofenac Potassium) for Febuxostat. The linearity was obtained in the concentration range of 5-25 μg/ml for Diclofenac Potassium and 2-10 μg/ml for Febuxostat. The mean recovery was 98.86-100.16% and 99.63-100.67% for Diclofenac Potassium and Febuxostat, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of Diclofenac Potassium and Febuxostat in pharmaceutical combined tablet dosage form. The results of analysis have been validated statistically and by recovery studies....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Eperisone Hydrochloride (EPE) and Diclofenac Sodium (DICLO) by employing first order derivative zero crossing method in Distilled water. The first order derivative absorption at 261 nm (zero cross point of Eperisone Hydrochloride) was used for quantification of Diclofenac Sodium and 249 nm (zero cross point of Diclofenac Sodium) for quantification of Eperisone Hydrochloride. The linearity was established over the concentration range of 4-20 µg/ml and 4-20 µg/ml for Eperisone Hydrochloride and Diclofenac Sodium with correlation coefficient r2 0.9987 and 0.9982, respectively. The mean % recoveries were found to be in the range of 99.97%–101.16% and 98.66%–100.13% for Eperisone Hydrochloride and Diclofenac Sodium, respectively. The proposed method has been validated as per ICH guideline and successfully applied to the estimation of Eperisone Hydrochloride and Diclofenac Sodium in Pharmaceutical Dosage Form....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for Simultaneous estimation of Olmesartan medoxomil (OLM), Amlodipine besylate (AML) and Hydrochlorothiazide (HCTZ) by employing first order derivative zero crossing method in Methanol and Distilled water (70:30). The first order derivative absorption at 237.51 nm (ZCP of OLM and AML) was used for quantification of HCTZ, 316.96 nm (ZCP of OLM and HCTZ) for quantification of AML and 296.03 nm (ZCP of AML and HCTZ) for quantification of OLM. The linearity was established over the concentration range of 4-20 μg/ml, 4-20 μg/ml and 3-15 μg/ml for OLM, AML and HCTZ with correlation coefficient (r2) of 0.99904, 0.99873 & 0.99980 respectively. The mean % recoveries were found to be in the range of 98.31%–98.5%, 100.75%–101.5% and 99.70%–99.86% for OLM, AML and HCTZ respectively. Inter-day and intra-day studies showed repeatability of the method. The method is successfully applied to pharmaceutical formulation, with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range. The proposed method has been validated as per ICH guideline and successfully applied to the simultaneous estimation of OLM, AML, & HCTZ in their combined Tablet dosage form. The proposed method is recommended for routine analysis since it is rapid, simple, accurate and also sensitive and specific....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for Simultaneous estimation of Paracetamol and Caffeine by employing first order derivative zero crossing method in Distilled water. The first order derivative absorption at 272.9 nm (zero cross point of Caffeine) was used for quantification of Paracetamol and 217.9 nm (zero cross point of Paracetamol) for quantification of Caffeine. The linearity was established over the concentration range of 5-25 μg/ml and 1-10 μg/ml for Paracetamol and Caffeine with correlation coefficient (r2) of 0.9987 and 0.9982 respectively. The mean % recoveries were found to be in the range of 99.52% – 99.88% and 98.39% – 98.66% for Paracetamol and Caffeine, respectively. Inter-day and intra-day studies showed repeatability of the method. The method is successfully applied to pharmaceutical formulation, with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range. The proposed method has been validated as per ICH guideline and successfully applied to the simultaneous estimation of Paracetamol (PCM) and Caffeine (CAF) in their combined Tablet dosage form. The proposed method is recommended for routine analysis since it is rapid, simple, accurate and also sensitive and specific by no heating and no organic solvents are required. Also use of Distilled water as a solvent makes it Cost effective and very economical method....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Paracetamol (PCM) and Tapentadol (TP) by employing first order derivative zero crossing method in methanol. The first order derivative absorption at 249 nm (zero cross point of Paracetamol) was used for quantification of tapentadol and 274 nm (zero cross point of tapentadol) for quantification of Paracetamol. The linearity was established over the concentration range of 4-12 µg/ml and 30-70 µg/ml for Paracetamol and Tapentadol with correlation coefficient r2 0.9993 and 0.9992, respectively. The mean % recoveries were found to be in the range of 98.85% – 99.56% and 98.70% – 99.69% for Paracetamol and Tapentadol, respectively. The proposed method has been validated as per ICH guideline and successfully applied to the estimation of pharmaceutical dosage form....
A new derivative spectroscopic method was developed and validated for the determination of Sildenafil citrate and Fluoxetine hydrochloride. Calibration curve for Sildenafil citrate and Fluoxetine hydrochloride over the concentration range 30-90 µg/ml were plotted and ZCP of Sildenafil citrate and Fluoxetine hydrochloride was found 226 nm and 263 nm respectively. The results of analysis have been validated statistically and by recovery studies. The value of standard deviation was satisfactory and recovery studies ranging from 99.03-100.0% for Sildenafil citrate and 100.25-100.93% for Fluoxetine hydrochloride were indicating of accuracy and precision of proposed method. The results of the assay are in good agreement with the label amount. The method was found to be simple, rapid, and accurate and can be adopted in routine analysis of Sildenafil citrate and Fluoxetine hydrochloride drugs in tablets....
First order derivative spectroscopy method involves the measurement of absorbance at zero crossing point of other drug. A new, rapid, precise, accurate and sensitive first derivative spectrophotometric method is proposed for the simultaneous estimation of Tizanidine hydrochloride and Mefenamic acid in pharmaceutical dosage form. The drugs obeyed the Beer’s law in the concentration range of 0.5-1.5 ug/ml (r2 = 0.9992) for Tizanidine hydrochloride and 6-19 ug/ml (r2 = 0.9994) for Mefenamic acid. In the proposed method, absorbance was measured at 252.58 nm (Zero Crossing Point of Mefenamic acid) for Tizanidine hydrochloride and 369.84 nm (Zero Crossing Point of Tizanidine hydrochloride) for Mefenamic acid. Accuracy of the method was determined by recovery studies and the average % recovery was found to be 99.63 % and 99.50 % for Tizanidine and Mefenamic acid respectively. The LOD for Tizanidine hydrochloride and Mefenamic acid were found to be 0.018 μg/ml and 0.049 μg/ml and LOQ were found to be 0.056 μg/ml and 0.1509 μg/ml respectively. Statistical analysis proves that the method is selective and sensitive for estimation of Tizanidine hydrochloride and Mefenamic acid in pharmaceutical dosage form. The results were found to be within acceptance criteria according to ICH Q2 R1 guideline....
A simple, precise, accurate, reproducible First order derivative Spectroscopic method was developed for the estimation of Rivaroxaban in bulk and dosage form. The study was conducted in Methanol. The method was found to be linear in the range of 2-12 μg/ml (r2=0.9998) for Rivaroxaban at λmax-238 nm and λmax-291 nm. The proposed method was validated for linearity, precision, accuracy and ruggedness according to ICH guideline for routine estimation purpose of drug in bulk and dosage form. Since the 1st derivative method has been developed and validated to ensure that the performance characteristic of the method meets the requirements for the intended analytical applications....
A simple, precise, accurate, reproducible First order derivative Spectroscopic method was developed for the simultaneous estimation of Montelukast Sodium and Olopatadine Hydrochloride in Combined dosage form using methanol. In this study the zero-crossing technique was used for spectral interpretaion. The method was found to be linear in the range of 10-50 μg/ml (r2=0.9994) for Montelukast sodium at 340.2 nm (Zero crossing point of Olopatadine Hydrochloride) and the range of 5-25 μg/ml (r2=0.9992) for Olopatadine Hydrochloride at 315.6 nm (Zero crossing point of Montelukast Sodium). The proposed method was validated for linearity, precision, accuracy and ruggedness according to ICH guideline for routine estimation purpose of these drugs in combined bulk dosage form. Since the 1st derivative method has been developed and validated to ensure that the performance characteristic of the method meets the requirements for the intended analytical applications....
A new, precise, simple, and accurate spectrophotometric method was developed for the Simultaneous estimation of Moxifloxacin HCl and Loteprednol Etabonate in combined dosage form. The combination is effective in Prophylaxis of Post Operative steroidal intra ocular infection where risk of bacterial population high. The simultaneous estimation of Moxifloxacin HCl and Loteprednol Etabonate involve absorbance measure at 228 nm (zero-crossover point of Moxifloxacin HCl) and at 243.20 nm (zero-crossover point of Loteprednol Etabonate) in first order Derivative mode. The formulation was evaluated for the percentage of content of both drugs at selected wavelength. Both the drug obeys Beer’s Lambert’s Law in the range of 5-30 µg/ml. the method was successfully applied to the formulation without any interference from incipient. The developed method was validated as per ICH guideline....
A rapid, sensitive and specific RP-HPLC method involving U.V. detection was developed and validated for the estimation of Cefixime and Linezolid in tablet dosage form. The method was validated in terms of linearity, accuracy, precision, specificity, robustness, limit of detection and limit of quantitation. The mobile phase used methanol: phosphate buffer in the ratio of 60:40 and pH adjusted to 3.5 with orthophosphoric acid. The detection of combined dosage form was carried out at 278 nm at constant flow rate of 1 ml/min. The retention time of Cefixime and Linezolid were found 3.304 min and 6.447 min respectively. Linearity was observed in 4-16 μg/ml for Cefixime (r2=0.998) and 12-48 μg/ml for Linezolid (r2=0.999). Detection limit for Cefixime and Linezolid is 0.159 μg/ml and 0.847 μg/ml respectively and quantification limit for Cefixime and Linezolid is 0.483 μg/ml and 2.566 μg/ml. The proposed method was successfully applied for the quantitative determination of Cefixime and Linezolid in tablet dosage form....
A new simple, sensitive high performance thin layer chromatographic (HPTLC) method has been developed for the quantitative estimation of Levosulpride (LEVO) and Pantoprazole Sodium (PANTO) in combined dosage form using silica gel 60 F254 TLC plate using Toluene: Ethyl Acetate: Methanol: Acetic Acid (7:2:1:0.2 v/v/v/v) as mobile phase. LEVO and PANTO showed Rf value 0.23 + 0.005 and 0.40+0.006 and scanned at 288 nm using a camag TLC scanner 3. The method was validated in terms of linearity 75-420 ng/spot for LEVO and 40-240 ng/spot for LEVO .The limit of detection and limit ofquantification for LEVO and PANTO were found to be 12.625 ng/spot and 8.996 ng/spot, respectively and limit of quantification for LEVO and PANTO were found to be 38.259 ng/spot and 27.262 ng/spot, respectively. The mean recovery was 98.36-101.05% and 98.37-102.00% for LEVO and PANTO respectively. The method was found to be simple, sensitive, specific, accurate and precise and can be used for the routine quality control testing of Levosulpride and Pantoprazole Sodium dosage form. The results of analysis have been validated statistically as per ICH guidelines....
A new, simple, accurate, precise, rapid, selective and reproducible high performance thin layer chromatographic method (HPTLC) for quantitative analysis of Zaltoprofen in pharmaceutical formulations has been established and validated. HPTLC on aluminium - backed silica gel 60F254 plates with chloroform: methanol, 8.5:1.5 (v/v) as mobile phase was followed by densitometry measurement at 258 nm. This system was found to give compact bands for Zaltoprofen at Rƒ 0.65. Calibration plots were linear in the range 100-600 ng per band with correlation coefficient 0.998. The recovery was in the range of 99.61-100.51%. The method was validated in accordance with ICH guidelines and can be used for analysis of marketed formulations....
A simple and sensitive high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of the levosulpiride and pantoprazole in their combined capsule dosage form. The chromatograms were developed using a mobile phase of ethyl acetate : toluene: methanol : Ammonia (5.5 : 3.0 : 1.5 : 0.2 v/v/v) on pre-coated plate of silica gel GF aluminium TLC plate and quantified by densitometric absorbance mode at 291 nm. This system was found to give compact spots for levosulpiride (Rf value of 0.24 ± 0.003) and pantoprazole (Rf value of 0.54 ± 0.008). The method was validated in terms of linearity, precision, accuracy, limit of detection, limit of quantification and specificity. The calibration curves were found to be linear between 100-500 ng/spot and 50-250 ng/spot for levosulpiride and pantoprazole, respectively. The proposed method was found to be reliable, reproducible and specific for the simultaneous estimation of levosulpiride and pantoprazole in their combined capsule dosage form....
A simple, sensitive and specific UV spectrophotometric method was developed for the estimation of Camylofin Dihydrochloride in tablet dosage form. Camylofin Dihydrochloride freely soluble in Water. So UV spectrophotometric estimation was done in water as solvent. The optimum conditions for the analysis of the drug were established. The wavelength maxima for Camylofin Dihydrochloride were found to be 257 nm in Water. Beer’s law was obeyed in the concentration range of 250-750 µg/ml. The slope, intercept, correlation coefficient, detection and quantization limits were also calculated. The proposed method has been applied successfully for the analysis of the drug in pure and in its pharmaceutical dosage forms....
A simple, accurate and precise Q-absorbance Ratio UV spectrophotometric method for the simultaneous estimation of Ambroxol Hydrochloride and Doxofylline in Bulk and Pharmaceutical Dosage forms has been developed and validated. The method is based on Q- Absorption Ratio method using two wavelengths, 243.5 nm (λmax of Ambroxol hydrochloride) and 255 nm (iso-absorptive point). Distilled water was used as a solvent in the method. The method was validated with respect to linearity, accuracy, precision and robustness as per the International Conference on Harmonisation (ICH) guidelines. The drug response with respect to absorbance was linear over the concentration range 1-50 µg/ml for both Ambroxol hydrochloride and Doxofylline. The percentage recovery of Ambroxol Hydrochloride and Doxofylline was found to be 99.75% and 100.11% respectively. The %R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully employed for the simultaneous determination of Ambroxol hydrochloride and Doxofylline in pharmaceutical formulations....
A simple, accurate and precise Q-absorbance Ratio spectrophotometric method for the simultaneous estimation of Aspirin and Esomeprazole magnesium in Bulk and Pharmaceutical Dosage forms has been developed and validated. The method is based on Q- absorption Ratio method using two wavelengths, 274 nm (λ max of Aspirin) and 239 nm (Iso-absorptive point). Methanol was used as a solvent in this method. The method was validated with respect to linearity, accuracy, precision as per the International Conference on Harmonisation (ICH) guidelines. The drug response with respect to absorbance was linear over the concentration range 20-50 µg/ml for Aspirin and 5-30 µg/ml for Esomeprazole magnesium. The percentage recovery of Aspirin and Esomeprazole magnesium was found to be 99.48% and 99.75% respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully employed for the simultaneous determination of Aspirin and Esomeprazole magnesium in pharmaceutical formulations....
A simple, accurate and precise Q-absorbance Ratio spectrophotometric method for the simultaneous estimation of Paracetamol and Tapentadol HCl in Bulk and Pharmaceutical Dosage forms has been developed and validated. The method is based on Q-absorption Ratio method using two wavelengths, 289 nm (λ max of Paracetamol) and 242.5 nm (Iso-absorptive point). 0.1 N Sodium Hydroxide was used as a solvent in this method. The method was validated with respect to linearity, accuracy, precision as per the International Conference on Harmonisation (ICH) guidelines. The drug response with respect to absorbance was linear over the concentration range 5-35 µg/ml for Paracetamol and 3-15 µg/ml for Tapentadol Hydrochloride. The percentage recovery of Paracetamol and Tapentadol Hcl was found to be 99.45% and 99.10% respectively. The %R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully employed for the simultaneous determination of Paracetamol and Tapentadol HCl in pharmaceutical formulations....
The present paper describes a simple, accurate and precise reversed phase HPLC method for rapid and simultaneous quantification of Ambroxol HCl, Guaifenesin and Levosalbutamol Sulphate in a cough syrup formulation. Separations were carried out on a phenomenex Luna C18 column (150 X 4.6 mm ID), 5 μm particle size. An isocratic elution system was developed using Methanol: Ammonium Acetate Buffer (50 mM) [45:55, v/v]. The elution of the analytes was achieved in less than 10 min with a flow rate of 1.0 ml/min. Detection was by UV absorbance at a wavelength of 236 nm. The detector response was linear in the concentration of 5-80 µg/ml for Ambroxol HCl, 10-120 µg/ml for Guaifenesin and 1-30 µg/ml for Levosalbutamol sulphate. The limit of detection (LOD) was found to be 0.019 µg/ml, 0.086 µg/ml and 0.0305 µg/ml, respectively and limit of quantitation (LOQ) values for AB, GF and LBS were found to be 0.057 µg/ml, 0.026 µg/ml and 0.092 µg/ml respectively. The intra and inter day variation was found to be less than 1%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of of Ambroxol Hcl, Guaifenesin and Levosalbutamol Sulphate in bulk and pharmaceutical formulations. All the parameters of validation were found in the acceptance range of ICH guideline....
Rifaximin is a structural analog of rifampin and a non-systemic, gastrointestinal site-specific antibiotic. Three simple, sensitive, precise and economical UV Spectrophotometric methods have been developed and validated in tablet formulation. Method A involved dissolving Rifaximin in chloroform and obtained an absorption maxima at 297 nm, Method B is based on first order derivative spectra which showed a sharp peak at 289 nm and Method C involved calculation of Area under Curve (AUC), that gives absorption in the wavelength range of 270-300 nm. Linearity for the detector response was observed in the concentration range of 2-20 µg/ml for method A and B, and 4-20 µg/ml for method C respectively. Results of the analysis were validated for accuracy, precision, Limit of detection (LOD), Limit of Quantitation (LOQ) and, found to be satisfactory. The proposed methods are simple, sensitivity, rapid, economical and suitable for the routine quality control application in pharmaceutical formulations....
A new, simple, precise, and accurate reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of Ambroxol Hydrochloride and Doxofylline in pharmaceutical dosage forms. Separation was carried out on Perkin Elmer HPLC system equipped Perkin Elmer LC- C18 column (250 X 4.6 mm, I.D. 5 μ) using Acetonitrile: Methanol: 20 mM Ammonium acetate buffer (pH 6.4) (30:45:25 v/v/v) as the mobile phase. The flow rate was adjusted to 1.0 ml/min with UV detection at 254 nm. The retention times of Ambroxol hydrochloride and Doxofylline were found to be 5.25±0.011 min and 2.90±0.01 min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of detection (LOD), and limit of quantitation (LOQ) were determined according to the International Conference on Harmonization (ICH) guidelines. The detector response was linear in the range of 1.0 to 4.0 μg/ml and 13.0 to 52.0 μg/ml for Ambroxol hydrochloride and Doxofylline respectively. The percentage recovery of Ambroxol hydrochloride and Doxofylline were obtained from the range of 99.24-100.7 % and 99.57-100.13% respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully applied for the simultaneous analysis of both drugs in tablet dosage forms and statistical analysis of the data revealed that the method is precise, accurate, reproducible, sensitive and suitable for the routine quality control analysis....
A simple, sensitive, accurate, precise and rapid reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Ambroxol hydrochloride, Levocetirizine dihydrochloride and Phenylephrine hydrochloride in combined dosage form. The chromatographic separation was performed on ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size). Mobile phase consisted of a mixture of phosphate buffer pH 6, acetonitrile and methanol in the ratio of 25: 10: 65, v/v/v at a flow rate of 0.8 ml/min. The detection wavelength was set at 230 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the concentration range of 2-30 μg/ml for Ambroxol hydrochloride, 2-30 μg/ml for Levocetirizine dihydrochloride and 2-30 μg/ml for Phenylephrine hydrochloride. The retention times were found to be 5.39±0.1 min for Ambroxol hydrochloride, 3.36±0.12 for Levocetirizine dihydrochloride and 2.49±0.13 for Phenylephrine hydrochloride. The mean recoveries were 100.06±1.52, 99.80±1.26 and 100.54±1.23 for Ambroxol hydrochloride, Levocetirizine dihydrochloride and Phenylephrine hydrochloride, respectively. The method can be easily adopted for quality control analysis....
A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Eperisone Hydrochloride (EPE) and Aceclofenac sodium (ACE) in synthetic mixture. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 2.75) Water (pH, 3.0):Acetonitrile: (52:8:20:20, v/v/v). The column used was ACE 5 phenyl, (150 mm x 4.6 mm i.d., 20.0 µl) with flow rate 1.00 ml/min using PDA detection at 255 nm. The method was linear over a concentration range 2-30 μg/ml for both drugs. The retention time of Aceclofenac sodium and Eperisone hydrochloride were found to 3.2 min and 2.4 min respectively. Results of analysis were validated statistically and by recovery studies. The mean recovery was 101.19±1.50 and 99.01±0.28 for EPE and ACE respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for EPE and ACE were found to be 0.36 and 1.09 µg/ml and 0.02 and 0.07 µg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine determination of EPE and ACE in mixture....
A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Eperisone Hydrochloride (EPE) and Diclofenac sodium (DIC) in synthetic mixture. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 6.0):Acetonitrile (40:10:50, v/v/v). The column used was Phenomenex C18, (250 mm x 4.6 mm i.d., 5 µm) with flow rate 0.7 ml/min using PDA detection at 265 nm. The method was linear over a concentration range 2-30 μg/ml for both drugs. The retention time of Diclofenac sodium and Eperisone hydrochloride were found to be 3.25 min and 6.44 min respectively. Results of analysis were validated statistically and by recovery studies. The mean recovery was 99.19±0.61 and 99.67±1.89 for EPE and DIC respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for EPE and DIC were found to be 0.6275 and 1.90 µg/ml and 0.3838 and 1.16 µg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine determination of EPE and DIC in mixture....
A simple, sensitive, accurate, precise and rapid reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Eperisone hydrochloride and Paracetamol from synthetic mixture. The chromatographic separation was performed on ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size). Mobile phase consisted of a mixture of phosphate buffer pH 6, acetonitrile and methanol in the ratio of 10: 30: 60, v/v/v at a flow rate of 0.7 ml/min. The detection wavelength was set at 255 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the concentration range of 2-50 μg/ml for Eperisone hydrochloride and 2-50 μg/ml for Paracetamol. The retention times were found to be 2.2±0.14 min for Diclofenac sodium and 3.9±0.13 min for Eperisone hydrochloride. The mean recoveries were 99.2±0.59 and 98.5±0.43 for Eperisone hydrochloride and Paracetamol, respectively. The method can be easily adopted for quality control analysis....
A Simple, Sensitive and precise reversed-phase High performance liquid chromatography method was developed and validated for the simultaneous determination of Losartan Potassium(LSK) and Atenolol (ATN) in tablet. The separation was achieved on RP C-18 (250 mm x 4.6 mm, 5 μm), using Methanol and Water (42:58 v/v) as mobile phase at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 226 nm. The method was validated. The developed and validated method was successfully applied for the quantitative analysis of Losar beta® tablet. The Calibration curves were linear over the ranges of 8-18 µg/ml for Losartan Potassium and Atenolol both. The retention time for Losartan Potassium and Atenolol was found to be 2.70 and 4.91 min, respectively. The percentage recovery was found to be 99.94% w/w and 100% w/w for Losartan Potassium and Atenolol, respectively. The values obtained of LODs were 0.01859 and 0.02882 µg/ml and LOQs were 0.05633 and 0.08732 µg/ml for Losartan Potassium and Atenolol, respectively. The proposed method is rapid, precise and accurate for the determination of Losartan Potassium and Atenolol for routine quality control of tablet containing these two drugs....
This paper presents a RP-HPLC method for the simultaneous estimation of Cefixime and Linezolid in combined tablet dosage form. The process was carried out on C18 column (Luna 5 μm, 250 × 4.60 mm, i.d) using phosphate buffer pH 5.5 and methanol in the ratio of 50:50 v/v respectively as a mobile phase at a flow rate of 1.2 mL/min. Detection wavelength was fixed at isobestic point 268 nm. Linearity was observed in the concentration range of 10-50 μg/ml for Cefixime (r2=0.9988) and 30-150 μg/ml for Linezolid (r2=0.9978). The retention time of Cefixime and Linezolid was found to be 2.671 and 6.987 minutes, respectively. The developed method is simple, precise, specific, robust, rapid, reproducible, and sensitive and it can be used for estimation of Cefixime and Linezolid in combined tablet dosage form....
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Gatifloxacin sesquihydrate (GAT) and Prednisolone acetate (PRD). The method showed adequate separation for Gatifloxacin sesquihydrate (GAT) and Prednisolone acetate (PRD) and best resolution was achieved with ACE 5 C18 column (150 mm x 4.6 mm i.d., 5 µm particle size) using Acetonitrile-Phosphate buffer pH 3-Methanol (30:50:20, v/v; pH adjusted to 3 with O-phosphoric acid and TEA (Tetra ethyl amine) as a mobile phase at a flow rate of 1.0 ml/min and wavelength of 267 nm. The calibration curves were linear over the concentration ranges of 2-30 μg/ml for Gatifloxacin sesquihydrate and 4-35 μg/ml Prednisolone acetate. The limit of detection (LOD) for GAT and PRD were found to be 0.69 µg/ml and 0.52 µg/ml, respectively. The limit of quantification (LOQ) values for GAT and PRD were found to be 2.09 µg/ml and 1.57 µg/ml respectively all the analytes were separated in less than 6.0 min. The proposed method could be applied for routine laboratory analysis of Gatifloxacin sesquihydrate and Prednisolone acetate in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations....
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Eperisone hydrochloride and Lornoxicam. The method showed adequate separation for Eperisone hydrochloride and Lornoxicam and best resolution was achieved with Phenomenex analytical C18, (250 mm × 4.6 mm × 5 μm) using methanol–Acetonitrile-water (40:25:35, v/v; pH adjusted to 3.0 with O-phosphoric acid and TEA) as a mobile phase at a flow rate of 1 ml/min and wavelength of 280 nm. The calibration curves were linear over the concentration ranges of 20-70 μg/ml for Eperisone HCl and 1.6-5.6 μg/ml for Lornoxicam. The limit of detection (LOD) and limit of quantification (LOQ) for Eperisone HCl were 1.0467 and 3.1718 μg/ml while for Lornoxicam were 0.0778 and 0.2357 μg/ml, respectively. All the analytes were separated in less than 5.0 min. The proposed method could be applied for routine laboratory analysis of Eperisone hydrochloride and Lornoxicam in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations....
The present manuscript describes simple, sensitive, rapid, accurate and precise methods for the determination of Bosentan monohydrate in pharmaceutical dosage form. Method A is the second order derivative spectroscopic method and Method B is RP-HPLC method. In the Method A; the measurements were carried out at wavelengths of 251 nm. The method was found to be linear (r2>0.9997) in the range of 5-30 μg/ml at 251 nm. The limit of detection was 0.6417μg/ml. The limit of quantification was 1.944 μg/ml. In the Method B; the separation was carried out using mobile phase consisting of buffer (pH-2.5): methanol: acetonitrile (30:40:30 v/v). The column used was Inertsil-ODS-3, (150 mm x 4.6 mm i.d., 3 µm) with flow rate 1 ml/min using PDA detection at 273 nm. The method was linear over a concentration range 5-30 μg/ml. The retention time was found to be 5.18 min. Results of analysis were validated statistically and by recovery studies. The mean recovery was 99.98±0.81. The limit of detection (LOD) and the limit of quantification (LOQ) were found to be 0.2315 and 0.7017 µg/ml respectively. Both methods were successfully applied for estimation of Bosentan monohydrate in pharmaceutical dosage form. The results of both the studies showed that the proposed validated methods were found to be simple, sensitive, precise and accurate and also useful for the routine determination Bosentan monohydrate in tablet dosage form....
Silodosin is a selective α1a adrenergic antagonist approved for benign prostatic hypertrophy. Three simple, sensitive, precise and economical UV Spectrophotometric methods have been developed and validated in tablet formulation of Silodosin. Silodosin dissolved in 0.1 N HCl has shown absorption maxima at 273 nm (Method A). Method B is based on first order derivative spectra which showed a sharp peak at 265 nm. Calculation of Area under Curve (AUC) in Method C, gave absorption in the wavelength range of 268-278 nm. A good linear relationship (0.999) was observed between the concentration ranges of 2-120 μg/mL. The assay of silodosin tablet was found to be 99.22%. The molar absorptivity was found be 3.68 x 104 L mole-1 cm-1 in all three methods. The inter-day and intra-day precision was observed as 100.28 and 99.61 respectively. The LOD and LOQ values were obtained in the range 0.45-0.47 µg and 1.432-1.436 µg/ml respectively, that were within the limits. These methods are therefore found as simple, sensitivity, rapid, economical and suitable for the routine quality control application in pharmaceutical formulations....
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of Eperisone Hydrochloride (EPE) and Lornoxicam (LOR) in combined dosage forms. The method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent. EPE has absorbance maxima at 255 nm and LOR has absorbance maxima at 288 nm in methanol. EPE (r2=0.999) and LOR (r2=0.995) showed linearity in the range of 2-30 µg/ml (both).The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The mean recovery was 99.5±0.26 and 99.87±0.35 for EPE and LOR, respectively. The method was successfully applied to the assay of the drugs in synthetic mixture, which were found in the range of 101.27% & 101.36% of the labeled value for both, Eperisone Hydrochloride and Lornoxicam, respectively. The suitability of this method for the quantitative determination of EPE and LOR was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of EPE and LOR in combination. The results of analysis have been validated statistically and by recovery studies....
A simple, accurate and precise UV spectrophotometric method for the simultaneous estimation of Aspirin and Esomeprazole magnesium in Bulk and Pharmaceutical Dosage forms has been developed and validated. The method is based on simultaneous method using two wavelengths, 274 nm (λmax of Aspirin) and 302 nm (λmax of Esomeprazole). Methanol was used as a solvent in this method. The method was validated with respect to linearity, accuracy, precision as per the International Conference on Harmonisation (ICH) guidelines. The drug response with respect to absorbance was linear over the concentration range 20-50 µg/ml for Aspirin and 5-30 µg/ml for Esomeprazole magnesium. The percentage recovery of Aspirin and Esomeprazole magnesium was found to be 99.62% and 99.79% respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully employed for the simultaneous determination of Aspirin and Esomeprazole magnesium in pharmaceutical formulations....
A simple and sensitive spectrofluorimetric method has been developed for estimation of Febuxostat (FEBU) in tablet dosage form. The thiazole moiety in FEBU acts as fluorophore. FEBU produces strong fluorescence at 378 nm (λem) with excitation at 316 nm (λex) in methanol. Linearity range was found to be 200-1000 ng/ml with mean recovery 100.038%. The correlation co-efficient was found to be 0.9993. The limit of detection (LOD) and limit of quantification (LOQ) for the developed method were found to be 13.406 and 40.625 ng/ml, respectively. The content of FEBU in marketed formulations was found to be 99.37% of labeled amount. The developed method was found to be specific, accurate and precise. It was successfully used for estimation of FEBU in its tablet dosage form....
A simple and sensitive spectrofluorimetric method has been developed for estimation of Levofloxacin in tablet dosage form. The piperazinyl moiety in Levofloxacin acts as fluorophore. Levofloxacin produces strong fluorescence at 455 nm (λem) with excitation at 289 nm (λex) in water. Linearity range was found to be 50-300 ng/ml with mean recovery 100.53%. The correlation co-efficient was found to be 0.9994. The limit of detection (LOD) and limit of quantification (LOQ) for the developed method were found to be 2.33 and 7.07 ng/ml, respectively. The content of Levofloxacin in two marketed formulations was found to be 99.44% and 99.77% of labelled amount. The developed method was found to be specific, sensitive, accurate and precise. It was successfully used for estimation of Levofloxacin in its tablet dosage form....
Simple, accurate and precise spectrophotometric and RP-HPLC methods were developed for simultaneous estimation of Diclofenac sodium and Chlorzoxazone in combined dosage form. In spectrophotometric method, methanol was used as solvent. Diclofenac sodium is treated with concentrated nitric acid. The reaction product was showing λmax at 360 nm. While Chlorzoxazone remains unreacted with nitric acid and showing λmax at 282 nm. The calibration curve is linear over the range of 4-12 μg /mL and 30-70 μg /mL, the LOD value were found to be 0.056 and 0.286 μg /mL, while LOQ value were found to be 0.170 and 0.866 μg /mL for Diclofenac sodium and Chlorzoxazone respectively. RP-HPLC method uses a Phenomenex C18, (250 mm × 4.6 mm × 5 μm) analytical column, mobile phase is Methanol:Water (70:30) pH 5.0 adjusted with Acetic acid was pumped at flow rate of 1 ml/min with UV detection at 282 nm. Retention time of Diclofenac sodium and Chlorzoxazone was 6.095±0.03 & 3.937±0.03, respectively with linearity range of 6-12 μg /mL and 30-70 μg /mL for Diclofenac sodium and Chlorzoxazone respectively. The LOD value were found to be 0.0033 and 0.0775 μg /mL, while LOQ value were found to be 0.01 and 0.235 μg / mL for Diclofenac sodium and Chlorzoxazone respectively....
Accurate, precise, rapid and economical UV Spectrophotometric first derivative method was developed for the estimation of Ampicillin Trihydrate and Cloxacillin Sodium in suspension dosage form. The principle for Area under Curve is “the area is measured around wavelength maxima of drug”. Area selected for Quantitation was 214.0-236.0 nm for Ampicillin (AMP) and 215.0-240.0 nm for Cloxacillin (CLO) in 0.1 N NaOH. Linearity observed in the concentration range was 10-30 µg/ml and 10-30 µg/ml for AMP and CLO respectively. The accuracy and precision were determined and found to comply with ICH guidelines....
Accurate, precise, rapid and economical UV Spectrophotometric first derivative method was developed for the estimation of Ampicillin Trihydrate and Cloxacillin Sodium in suspension dosage form. The principle for First - Derivative method is “the height is measured at wavelength maxima of two drugs”. Wavelengths selected for Quantitation were 216.0 nm for Ampicillin and 217.0 nm for Cloxacillin in 0.1N NaOH. Linearity observed in the concentration range was 10-30 µg/ml and 10-30 µg/ml for AMP and CLO respectively. The accuracy and precision were determined and found to comply with ICH guidelines....
UV Spectrophotometric method has been developed for simultaneous estimation of Cefixime (CEF) and Linezolid (LNZ) in bulk drug and combined tablet dosage form. This method utilizes methanol as a solvent and λmax of Cefixime and Linezolid selected for analysis was found to be 290 nm and 259 nm respectively. Linearity was observed in the concentration range of 6-14 μg/ml for Cefixime (r2=0.999) and 7-15 μg/ml for Linezolid (r2=0.999).The method was validated statistically and by recovery studies. The mean % recovery was 99.46-101.11 % and 99.34-101.77 % for Cefixime and Linezolid respectively. The proposed procedure was successfully applied for the simultaneous determination of both drugs in commercial tablet preparation. The results were found to be within acceptance criteria according to ICH guideline. This method was simple, rapid, accurate and sensitive....
UV Spectrophotometric method has been developed for simultaneous estimation of Ceftazidime (CTZ) and Clavulanic acid (CA) in bulk drug and in Pharmaceutical dosage form. This method utilizes distil water as a solvent and λmax of Ceftazidime and Clavulanic acid is selected for analysis was found to be 256 nm and 278 nm respectively. Linearity was observed in the concentration range of 4-20 μg/ml for Ceftazidime (r2=0.9991) and 50-250 μg/ml for Clavulanic acid (r2=0.9983). The method was validated statistically and by recovery studies. The mean % recovery was 99.87-99.89 % and 99.75-100.35 % for Ceftazidime and Clavulanic acid respectively. Developed method was applied to pharmaceutical dosage form. The results were found to be within acceptance criteria according to ICH guideline. This method was simple, rapid, accurate and sensitive....
Meropenem (MERO) and Sulbactam (SUL) are used in combination in treatment of lower respiratory tract infections. Two simple, accurate, precise, economical and reproducible UV spectrophotometric methods have been developed for the estimation of Meropenem and Sulbactam in Pharmaceutical formulation. Method I- absorption ratio method (Q-analysis) using two wavelengths, 283 nm (isobestic point at which both the drugs exhibit absorbance) and 257.6 nm (λmax of Sulbactam) and Method II-First Derivative method using two wavelengths, 254 nm (ZCP of Meropenem) and 321 nm (ZCP of Sulbactam). Linearity for detector response was observed in the concentration range of 10-50 µg/ml & 5-25 µg/ml for Meropenem and Sulbactam respectively. The results of analysis have been validated statistically and by recovery studies the value of standard deviation was satisfactory and recovery studies ranging from 99.00-100.50% for Meropenem and 98.88-101.00% for Sulbactam in method-I and 99.72-100.50% for Meropenem and 98.00-100.45% for Sulbactam in method-II were indicative of the accuracy and precision of the proposed method. The proposed methods were successfully applied for the determination of Meropenem and Sulbactam in commercial pharmaceutical preparation. All two methods were validated statistically as per ICH guidelines....
UV Spectrophotometric method has been developed for simultaneous estimation of Paracetamol (PCM) and Tapentadol Hydrochloride (TP) in bulk drug and in Pharmaceutical dosage form. This method utilizes methanol as a solvent and λmax of Paracetamol and Tapentadol is selected for analysis was found to be 249 nm and 274 nm respectively. Linearity was observed in the concentration range of 4-12 μg/ml for Paracetamol (r2=0.999) and 30-70 μg/ml for Tapentadol (r2=0.999). The method was validated statistically and by recovery studies. The mean % recovery was 99.63-100.83 % and 98.30-100.98 % for Paracetamol and Tapentadol respectively. Developed method was applied to pharmaceutical dosage form. The results were found to be within acceptance criteria according to ICH guideline. This method was simple, rapid, accurate and sensitive....
Ilaprazole is a substituted benzimidazole that inhibits gastric acid secretion and used for the treatment of erosive or ulcerative GERD, DU and hypersecretory syndromes. In present work, a simple, sensitive, accurate and economical spectroscopic method has been developed for the estimation of Ilaprazole in Bulk and its pharmaceutical dosage forms. An absorption maximum was found to be at 306 nm with the solvent system Methanol. The drug follows Beer law in the range of 6-18 μg/ml with correlation coefficient of 0.9999. The percentage recovery of Ilaprazole ranged from 99.6 to 100.41 % in pharmaceutical dosage form. Results of the analysis were validated for accuracy, precision, LOD, LOQ and were found to be satisfactory. The proposed method is simple, rapid and suitable for the routine quality control analysis....
The aim of present work is to develop and validate simple, sensitive and specific spectrophotometric method for the determination Bi-Ciprofloxacin-2, 2-bipyridyl metal complex. UV spectrophotometric method is based on measurement of absorption at maximum wavelength at 281 nm by using methanol. The parameters such as Linearity Range, Precision, Accuracy, Repeatability, Ruggedness, Limit of quantification, Limit of detection according to US FDA guidelines. In the UV spectroscopic method linearity over the concentration range of metal complex was found to be 2-70 µg/ml with a correlation coefficient 0.999. The developed method was validated with respect to linearity, accuracy and precision. The method was found to be simple, accurate, precise, economical and robust....
A simple, precise, accurate and reproducible UV spectrophotometric method (1st derivative) has been developed for simultaneous estimation of Celecoxib and Diacerein in bulk and combined dosage form using a double beam UV-Visible spectrophotometer using Methanol as solvent and spectra converted to 1st derivative and absorbance measured at two wavelengths i.e. 251.8 nm (Zero crossing point of Celecoxib) and 254.6 nm (Zero crossing point of Diacerein). The linear correlation was obtained for Celecoxib and Diacerein in the concentration ranges of 4-20 μg/ml and 2-10 μg/ml with correlation co-efficient 0.999 and 0.999 respectively. The mean recoveries were found to be 100.49% & 100.42% for Celecoxib and Diacerein respectively. Since the 1st derivative method has been developed and validated to ensure that the performance characteristic of the method meets the requirements for the intended analytical applications....
A simple, precise and accurate Stability indicating reversed phase liquid chromatographic method was developed and validated for estimation of tablet formulation. The separation was achieved on The HPLC system (Shimadzu VP, Japan), consisted of a system controller (SCL-10AVP), on-line degasser (DGU-14A), & mixture of Buffer (pH 5.5): Methanol (30:70) was used as mobile phase with flow of 1.2 ml/min with UV detection at 254 nm. The method was successfully validated in accordance to ICH guidelines for accuracy, precision, specificity, ruggedness, robustness and linear in the concentration range 20-100 ppm....
A UV quantification spectrophotometric method was developed for detection of Diclofenac potassium which is economical, simple, safe, and specific. The samples were used for degradation studies by using the developed method. The absorbance maximum (λmax) of the Diclophenac potessium was found to be 209 nm. The method reveals high sensitivity, with linearity in the 2 to 10 µg/ml range. The lower limit of detection was found to be 0.05 µg/ml and the limit of quantification was found to be 0.15 µg/ml. All the calibration curves demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.99. The regression equation of the curve was Y=0.106x + 0.354. The precision of the method was found to be 1.430±0.02162. The % recovery was found to be 101.31%....
The present research work aims to develop a simple, sensitive, accurate and reproducible method for the estimation of Avanafil by spectrophotometric method. An absorbance maximum for Avanafil was found to be at 307 nm using methanol as a solvent. Linearity for Avanafil was observed in concentration range of 5-35 μg/ml. The obtained correlation coefficient was 0.9992. The accuracy was evaluated by recovery study and recovery result was obtained between 101.69 % to 102.10 % and the relative standard deviation below 2% was achieved. Validation was done as per ICH guidelines. Proposed method can estimate Avanafil in Tablet dosage form without the interference of common excipients....
A simple and economic UV spectrophotometric method for the simultaneous determination of betamethasone valerate and neomycin sulphate in pharmaceutical dosage form was developed. Betamethasone is a glucocorticoid. It is widely used in pharmaceutical preparation. Neomycin is an aminoglycosidic antibiotic, widely used against Gram-negative bacteria. Because of its advantages (simplicity, low cost and accessible instruments), Ultraviolet spectrophotometry represents a suitable method for the quantitative determination of pharmaceutical active ingredients in raw materials and marketed formulation. All readings were performed at two wavelengths 235 nm and 274 nm for betamethasone valerate and neomycin sulphate respectively. Accuracy was determined by spiking standards and the recoveries of betamethasone valerate and neomycin sulphate were found to be between 99.16-100.8% and 99.70-100.86% respectively. The method was validated and proved to be linear. The developed method is also the first report on the simultaneous determination of betamethasone valerate and neomycin sulphate in pharmaceutical preparation....
A simple, sensitive and specific UV Spectrophotometric method was developed for the estimation of ilaprazole in tablet dosage form. The optimum conditions for the analysis of the drug were established. The wavelength maximum (λmax) for ilaprazole was found to be 306 nm. Beer’s law was obeyed in the concentration range of 1‐10 mcg mL‐1 with 23.36×103 L mol‐1 cm‐1, the slope, intercept, correlation coefficient, detection and quantization limits were also calculated. The proposed method has been applied successfully for the analysis of the drug in pure and in its tablets dosage forms....
A simple, accurate, cost effective and reproducible spectrophotometric method has been developed for the estimation of Dexketoprofen in bulk and pharmaceutical dosage form. An absorption maximum was found to be at 225 nm. The percentage recovery of Dexketoprofen was found to be 99.7169 % in pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy (recovery), precision, LOD, LOQ, Sandell’s sensitivity, molar absorbtivity, and specificity. Beer’s law was obeyed in the concentration range of 10-50 µg/ml having line equation y = 0.2238 x + 0.0212 with correlation coefficient of 0.9993....
A new absorption ratio method was developed and validated for the determination of Dexketoprofen Tromatamol and Dicyclomine HCl in Bulk and binary mixture. The method involved Q-absorption analysis based on the measurement of absorbance at two wavelengths, i.e. λmax of Dexketoprofen Tromatamol (260.0 nm) and iso-absorptive point of both drugs (243.0 nm). Beer’s law was obeyed in the concentration range between 3-7 μg/ml for Dexketoprofen Tromataml and 15-25 μg/ml for Dicyclomine HCl. The results of analysis have been validated statistically and by recovery studies. The method was found to be simple, precise, reproducible, less time consuming and economical. Hence it is more suitable for routine analysis of these drugs in combined dosage forms....
A new derivative spectroscopy method was developed and validated for the determination of Dexketoprofen Tromatamol and Dicyclomine HCl in Bulk and binary mixture. The method involved 1st derivative spectroscopy based on the measurement of absorbance at two Zero crossing points, i.e. ZCP of Dexketoprofen Tromatamol (247.0 nm) and ZCP of Dicyclomine HCl (233.0 nm). Beer’s law was obeyed in the concentration range between 9-24 μg/ml for Dexketoprofen Tromataml and 10-60 μg/ml for Dicyclomine HCl. The results of analysis have been validated statistically and by recovery studies. The method was found to be simple, precise, reproducible, less time consuming and economical. Hence it is more suitable for routine analysis of these drugs in combined dosage forms....
A simple, accurate and precise dual wavelength spectrophotometric method was developed for simultaneous determination of Dexketoprofen Tromatamol and Dicyclomine HCl in laboratory binary mixture. The principle for dual wavelength method is “the absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The wavelengths selected for determination of Dexketoprofen Tromatamol were 205 nm and 211 nm, whereas, the wavelengths selected for determination of Dicyclomine HCl were 239 nm and 287 nm. Dist. Water was taken as a solvent. Regression analysis of Beer’s plots showed good correlation in concentration range of 9-24 μg/ml for Dexketoprofen Tromatamol and 10-60 μg/ml for Dicyclomine HCl. Accuracy of method was found between 98‐102 percent. The precision (intra‐day, inter‐day and repeatability) of method was found within limits. The proposed method was successfully applied to determination of these drugs in mixture....
A new derivative spectroscopy method was developed and validated for the determination of Dexketoprofen Tromatamol in Bulk and formulation. The method involved zero order and 1st derivative spectroscopy based on the measurement of absorbance at Zero crossing point, i.e. ZCP of Dexketoprofen Tromatamol (247.0 nm) for 1st order and (260 nm) for zero order. Beer’s law was obeyed in the concentration range between 9-24 μg/ml for Dexketoprofen Tromatamol. The results of analysis have been validated statistically and by recovery studies. The method was found to be simple, precise, reproducible, less time consuming and economical. Hence it is more suitable for routine analysis of these drugs in combined dosage forms....
A new simple, sensitive and economic absorption ratio method was developed and validated for the determination of Eperisone hydrochloride and Diclofenac sodium in Bulk and pharmaceutical formulation. The method involves Q-absorption analysis based on the measurement of absorbance at two wavelengths, i.e. λ max of Eperisone hydrochloride (261.0 nm) and Iso-absorptive point of both drugs (280.0 nm). Beer’s law was obeyed in the concentration range between 3-24 μg/ml for Eperisone hydrochloride and 5-40 μg/ml for Diclofenac sodium. The solutions were prepared in distilled water. The results of analysis have been validated statistically and by recovery studies. The method was found to be simple, precise, reproducible, less time consuming and economical. Hence it is more suitable for routine analysis of these drugs in combined dosage forms....
A simple, sensitive and economic spectrophotometric method has been developed for simultaneous determination of Eperisone hydrochloride and Diclofenac sodium in a pharmaceutical formulation. In the proposed method, the absorbances were measured at 261.0 nm and 275.0 nm corresponding to the absorbance maxima of Eperisone hydrochloride and Diclofenac sodium in Dist. Water respectively. Linearity range was observed in the concentration range of 3–24 μg/ml for Eperisone hydrochloride and 5-40 μg/ml for Diclofenac sodium. Concentration of each drug was obtained by using the absorptivity values calculated for both drugs at two wavelengths, 261.0 nm and 275.0 nm and solving the simultaneous equation. The method was validated statistically and recovery study was performed to confirm the accuracy of the method. The method was found to be rapid, simple, accurate and precise....
A simple, sensitive and economic spectrophotometric method has been developed for determination of Eperisone hydrochloride in a pharmaceutical formulation. In the proposed method, the absorbances were measured at 261.0 corresponding to the absorbance maxima of Eperisone hydrochloride in distilled Water. Linearity range was observed in the concentration range of 3–24 μg/ml for Eperisone hydrochloride. Concentration of each drug was obtained by the calibration curve of absorbance vs concentration plotted. LOD and LOQ were found to be 0.214 and 0.649 respectively. The method was validated statistically and recovery study was performed to confirm the accuracy of the method. The method was found to be rapid, simple, accurate and precise....
Zero-order UV-Spectrophotometric methods have been developed and validated for the estimation of Nizatidine in bulk and its tablet formulations. The solutions of standard and sample were prepared in water. Nizatidine was estimated at 327 nm for the zero order UV-Spectrophotometric method. Beer’s law was obeyed in the concentration range of 2-10 μg/ml with r2 value 0.999 for zero order. This method was tested and validated for various parameters according to ICH guidelines. The proposed method was successfully applied for the determination of Nizatidine in tablet formulations....
A simple, precise, accurate, reproducible Simultaneous equation UV Spectroscopic method was developed for the simultaneous estimation of Montelukast Sodium and Olopatadine Hydrochloride in Combined dosage form using methanol. The wavelength maximum for Montelukast sodium and Olopatadine Hydrochloride was selected to be 283 nm and 304 nm. The method was found to be linear in the range of 10-50 μg/ml (r2=0.9991) for Montelukast sodium at 283 nm and the range of 5-25 μg/ml (r2=0.9992) for Olopatadine Hydrochloride at 304 nm. The proposed method was validated for linearity, precision, accuracy and ruggedness according to ICH guideline for routine estimation purpose of these drugs in combined bulk dosage form. Since this method has been developed and validated to ensure that the performance characteristic of the method meets the requirements for the intended analytical applications....
A simple, sensitive and specific UV Spectrophotometric method was developed for the estimation of Vardenafil in tablet dosage form. The wavelength maximum (λ max) for Vardenafil was found to be 240.0 nm. Beer’s law was obeyed in the concentration range of 5‐25 mcg mL‐1 with 9.685 × 103 L mol‐1 cm‐1, slope, intercept, correlation coefficient, detection and quantization limits were also calculated. The proposed method has been applied successfully for the analysis of the drug in pure and in its tablet dosage forms....
A simple and sensitive UV-spectrophotometric method has been developed for simultaneous determination of Salbutamol sulphate, Ambroxol HCl and Dextromethorphan HBr in a combined pharmaceutical dosage form. In the proposed method, the absorbances were measured at 224 nm 244 nm and 277 nm corresponding to the absorbance maxima of Salbutamol sulphate, Ambroxol HCl and Dextromethorphan HBr in methanol respectively. Linearity range was observed in the concentration range of 10-50 μg/ml. Concentration of each drug was obtained by using the absorptivities calculated for all three drugs at wavelengths, 224 nm, 244 nm and 277 nm and solving the simultaneous equation. Developed method was applied to pharmaceutical formulation. The method was validated statistically and recovery study was performed to confirm the accuracy of the method. The method was found to be rapid, simple, accurate and precise....
Bupivacaine is chemically (RS)-1-butyl-N-(2, 6-dimethylphenyl) piperidine-2-carboxamide is used for the local anaesthetic. As Bupivacaine hydrochloride is official in IP, BP, and USP, no official analytical method is there for estimation of this drug. Literature survey reveals few analytical methods like liquid chromatography, stability indicating HPLC, colorimetric and biological assay are reported; there was no mention of a method based on spectrophotometric estimation. The present work describes a validated zero and first order derivative Spectrophotometric method measurement for estimation of Bupivacaine. The present work describes a validated Zero and first order derivative Spectrophotometric method for estimation of Bupivacaine in bulk and in parentral formulation. The solvent used was Sodium Hydroxide dilution. An absorbance maximum in zero order is and first order derivative spectra was found at Absorbance minima at 272 nm, the drug followed a linear relationship in the range of 10-35μg/ml while the correlation coefficient was found 0.999. The recovery was 99.89% and the coefficient of variance for intraday and interday was found to be less than 5%, LOD and LOQ for this method was found 10μg/ml and 35μg/ml respectively. The proposed UV- Visible spectrophotometric method is a simple, specific, rapid, accurate, economic and found suitable for day to day analysis of Bupivacaine in bulk and its formulation....
In the present work, simple, sensitive, specific, and validated colorimetric method has been developed for the quantitative estimation of Voriconazole in bulk and pharmaceutical dosage form. Voriconazole in presence of acidic medium reacts with excess amount of Chloramine-T and unreacted Chloramine-T reacts with crystal violet to produce blue colour. The λmax was found to be 580 nm for assay. The linearity was found in concentration range of 5-30 µg/ml. The correlation coefficient was found 0.9992. The regression equation was found as Y= 0.020 X + 0.00. The method was validated for linearity, accuracy, precision and ruggedness. The LOD and LOQ for estimation of voriconazole were found as 0.02250 & 0.06819 respectively. Recovery of Voriconazole was found to be 98.73 %. Proposed method was successfully applied for the quantitative estimation of voriconazole in marketed formulations....
The present work describes a validated Reverse-phase High Performance Liquid Chromatographic method for simultaneous estimation of Cefpodoxime Proxetil and Ofloxacin in tablet dosage form. The separations were achieved using Inertsil C18 column, 5 µm, {250 mm × 4.6 mm (i.d.)} with a mobile phase consisting of 0.05 M KH2PO4 buffer (pH 3.0 adjusted with 0.1% orthophosphoric acid): Methanol: Acetonitrile (40:40:20 v/v/v), at the flow rate of 1.0 mL/min. Detection was carried at 235 nm using a variable wavelength UV-2070/2075 Plus detector. The retention time for Ofloxacin was about 3.167 minute and for Cefpodoxime Proxetil I and Cefpodoxime Proxetil II were about 12.933 and 14.451 minute respectively. The linearity range for Cefpodoxime Proxetil and Ofloxacin was 6.5-32.5 g/ml and 5-25 µg/ml, respectively. The proposed method was found to be accurate, precise, specific, and rugged and thus can be used for simultaneous estimation of Cefpodoxime Proxetil and Ofloxacin in tablet formulation....
A simple, sensitive, accurate, precise and cost-effective UV spectrophotometric method was developed for estimation of eperisone hydrochloride in tablet dosage form. Optimum conditions for the estimation were established. Shimadzu UV-1800 was used for the purpose. Double distilled water was used as solvent system. Active pharmaceutical ingredient was received with thanks from Sun Pharmaceutical Industries. SKELACT (Sun Pharma, Maharashtra) and RAPISONE tablets (Abbott, Maharashtra) were procured from local market. A wavelength maximum was found to be at 261.40 nm. Beer’s law was found to be followed in the linearity range of 2-20 µg/ml. with molar absorptivity of 14718.93. Validation parameters were also calculated. Student t-test was applied to check any significant difference between labelled claim and experimental values. The method can be successfully applied for routine analysis of eperisone hydrochloride in bulk and tablet dosage form....
A simple, precise and sensitive UV method has been develop for the estimation of Isoniazid (INH) in bulk drug form by Difference Spectrophotometric method. Isoniazid has exhibited maximum absorbance at about 266 nm and 270 nm in acidic and basic solution respectively. Beer's law was obeyed in the concentration range of (10-50) mcg/ml in both the cases. The proposed methods were successfully applied for the determination of Isoniazid in bulk drug. As per ICH guidelines the results of the analysis were validated statistically and were found to be satisfactory....
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