Current Issue : January-March Volume : 2014 Issue Number : 1 Articles : 19 Articles
A simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the estimation of Ilaorazole in Tablet dosage form. C18 (hypersil column) 5mm column having 250Ã?â??4.6 mm id in Isocratic mode with mobile phase containing orthophosphoric acid: methanol (70:30) was used. The flow rate was 1 ml/min and effluents were monitored at 226 nm. The retention time of Ilaprazole is 4.1. The calibration curve was linear over a concentration range from 10 Ã?µg/ml-30 Ã?µg/ml for Ilaprazole.Limit of detection (LOD) and Limit of quantitation (LOQ) were 0.05865 Ã?µg/ml and 0.195503 Ã?µg/ml for Ilaprazole respectively. The developed method was fast, accurate, precise and successfully applied to estimate the amount of Ilaprazole in bulk sample and tablet dosage form so it can be used for regular quality control of the drug....
Estimation of Paracetamol and Tapentadol in tablet dosage form is routinely carried out but simultaneous estimation of the combination is not available. Hence a simple, rapid, sensitive, economic, and accurate HPLC method has been developed and validated for simultaneous estimation of Paracetamol and Tapentadol in bulk and tablet dosage form. The chromatographic separation was performed in waters e 2695 equipment using mobile phase consisting of OPA and methanol in ratio of 70:30. The column used was Zorbax c18 (150Ã?â??4.6mm ID) 5Ã?µ with flow rate 1 ml/min using PDA detector at 301nm. The RT was found to be 2.954 for paracetamol and 3.651 for Tapentadol. The described method was found to be linear and correlation coefficient was found to be 0.99. The validation of proposed method was carried for its accuracy, precision, and specificity, limit of detection and limit of quantitation for both paracetamol and Tapentadol. The assay values for paracetamol and Tapentadol was found to be 99% and 100%. The results showed that proposed RP-HPLC method is simple precise, reliable, accurate and economical which is useful for routine determination of paracetamol and Tapentadol in bulk drug and its pharmaceutical dosage form....
A simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Paracetamol and Flupirtine in Tablet dosage form. A YMC C18 5mm column having 250 x 4.6mm id in Isocratic mode with mobile phase containing 0.1M Potassium dihydrogen phosphate: methanol (70:30 ) was used. The flow rate was 0.8ml/min and effluents were monitored at 271nm. The method was validated for Accuracy, Precision, Specificity, Linearity and Sensitivity. The retention times of Paracetamol and Flupirtine were 1.8min and 3.0min respectively. The calibration curves were linear over a concentration range from 81.25-243.75 �µg/ml for Paracetamol and over a concentration range from 25-75 �µg/ml for Flupirtine. Limit of detection (LOD) and Limit of quantitation (LOQ) were 3.83 and 12.77 for Paracetamol and 1.05 and 3.51 for Flupirtine respectively. The developed method was fast, accurate, precise and successfully applied to estimate the amount of Paracetamol and Flupirtine in bulk sample and tablet dosage form so it can be used for regular quality control of the drug....
Clobetasol Propionate is a topical corticosteroid (an analogue of prednisolone) having a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity, used in treatment of psoriasis,eczema and other topical dermatological purposes.It act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. The clinical and pharmaceutical analysis of this drug requires effective analytical procedures for quality control and pharmacodynamic and pharmacokinetic studies as well as stability study. An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the instrumental analytical methods which were developed and used for determination of clobetasol propionate as single or combination with other drugs in bulk drugs, formulations and biological fluids have been reviewed. This review covers 14 analytical methods including spectrophotometric methods like spectrophotometry through charge transfer complexation; chromatographic method including HPLC, LC-MS,HPLC-UV-MS and miscellaneous method like linear sweep adsorptive stripping voltammetry were reported. The application of these methods for the determination of clobetasol propionate in pharmaceutical dosage forms and biological samples has also been discussed....
A simple, precise, accurate and reproducible spectrophotometric method has been developed for simultaneous estimation of Ceftazidime (CTZ) and Clavulanic acid (CA) by employing area under curve method in dist.water. The area at 250-260 nm was used for quantification of Ceftazidime and 275-285 nm for quantification of Clavulanic acid. The linearity was established over the concentration range of 4-20 Ã?µg/ml and 50-250 Ã?µg/ml for Ceftazidime and Clavulanic acid with correlation coefficient r2 0.9951 and 0.9956, respectively. The mean % recoveries were found to be in the range of 99.91 % ââ?¬â?? 99.93 % and 99.68 % ââ?¬â?? 100.08 % 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....
A sensitive, specific, precise and accurate high performance liquid chromatographic method of analysis of a mucolytic drug Erdosteine was developed and validated. The method employed in Kromasil ODS C18 (100 x 4.6 mm 5.0�µ) column as a stationary phase. The mobile phase contains a mixture of Acetonitrile, Phosphate buffer pH adjusted to 2.5 using phosphoric acid and Triethylamine. It is pumped isocratically through the chromatographic system at a flow rate of 1.0 ml minute. UV detector was operated at 236 nm. The analyte peak was eluted at retention time of 3.02 minutes .The method was found to be linear over a range of 2- 10 �µg/ml. The developed Method was validated as per ICH guidelines. The developed method is thus having a thorough output in the estimation of Erdosteine in bulk drug....
Tazarotene and Mometasone furoate is in fixed dose combination (Cream), used in plaque psoriasis. A simple, precise, rapid, accurate and specific RP-HPLC method have been developed and validated to determine Tazarotene (TAZA) and Mometasone Furoate (MOMETAS), in cream formulation. The RP-HPLC method was developed and validated for simultaneous estimation of Tazarotene and Mometasone furoate in its formulation using Lichrosphere C18 column (250 X 4.6mm, 5 �µm) as stationary phase and Methanol: Water in the proportion of 90:10, v/v and the pH of mobile phase was adjusted to 3.8 using 0.5% v/v Orthophosphoric acid. The detection was carried out at 248 nm using UV detector keeping the flow rate of 1.0 ml/min and injection volume 20 �µl. Retention time of Tazarotene and Mometasone furoate was found to be 8.31 and 3.51 min, respectively. Linearity was found over the concentration range of 1-5 �µg/ml for TAZA (R2 = 0.9992) and 1-5 �µg/ml for MOMETAS (R2 = 0.9994) with mean recoveries of 98.00-100.67% for TAZA and 99.00-100.11% MOMETAS, respectively. The LOD was found to be 0.0155 �µg mL-1 for TAZA and 0.0103 �µg mL-1 for MOMETAS. The LOQ was found to be 0.0469 �µg mL-1 for TAZA and 0.0307 �µg mL-1 for MOMETAS. The assay percentage was comparable with the label claim percentage for both TAZA and MOMETAS. The method was validated as per ICH guidelines Q2 (R1).The method was successfully applied for the determination of TAZA and MOMETAS in their cream formulation....
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric simultaneous equations method for estimation of Betahistine Dihydrochloride and Prochlorperazine Maleate in Tablet Dosage Form. The method is based on the simultaneous equations for analysis of both the drugs using 0.1 N HCl as solvent. Betahistine Dihydrochloride has absorbance maxima at 261 nm and Prochlorperazine Maleate has absorbance maxima at 254 nm in 0.1 N HCl. The linearity was obtained in the concentration range of 4-25 �µg/ml and 4-22 �µg/ml for Betahistine Dihydrochloride and Prochlorperazine Maleate, respectively. The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The mean recovery was 98.75 �± 0.82 and 99.58 �± 0.16 for Betahistine Dihydrochloride and Prochlorperazine Maleate, respectively. The method was successfully applied to Tablet Dosage Form because no interference from the mixture excipients was found. The suitability of this method for the quantitative determination of Betahistine Dihydrochloride and Prochlorperazine Maleate was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of Betahistine Dihydrochloride and Prochlorperazine Maleate in combination. The results of analysis have been validated statistically and by recovery studies....
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for estimation of Nicotine in Nicotine polacrilex gum. The method is based on the simple spectrophotometric analysis of nicotine using water as extracting solvent. Nicotine has absorbance maxima at 260 nm in water. The linearity was obtained in the concentration range of 10-60 �µgs/ml. The concentration of the drugs was determined by using regression equation. The mean recovery was 98.55 �± 0.47 for Nicotine. The method was successfully applied to Gum tablet because no interference from the mixture excipients was found. The suitability of this method for the quantitative determination of Nicotine was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of Nicotine in gum tablet. The results of analysis have been validated statistically and by recovery studies....
Development and validation of UV Spectrophotometric method for simultaneous estimation of Tizanidine hydrochloride and Mefenamic acid in their combined tablet dosage form. For this dual wavelength method, where 246 nm and 261 nm were selected as ?1 and ?2 for the determination of Tizanidine hydrochloride and 230 nm and 245 nm were selected as ?1 and ?2 for the determination of of Mefenamic acid. Tizanidine hydrochloride showed linearity in the range of 0.5-1.5�µg/mL and Mefenamic acid showed linearity in the range of 6-9 �µg/mL in all the methods. Method was validated statistically and recovery studies were carried out. This method was found to be accurate, precise and reproducible. This method was applied to the assay of the drugs in marketed formulation, which were found in the range of 98.0% to 100.0% of the labelled value for both Tizanidine hydrochloride and Mefenamic acid. New, simple, accurate and precise UV spectrophotometric method have been developed and validated for the simultaneous determination of Tizanidine hydrochloride (TZN) and Mefenamic acid (MEF) in their combined dosage form....
Without resolving mixtures of Formoterol fumarate dihydrate and Beclomethasone dipropionate, simultaneous estimation has been successfully achieved by spectrophotometry. Simultaneous equation method employs formation and solving of mathematical simultaneous equation using 214nm and 239nm wavelength of Formoterol fumarate dihydrate and Beclomethasone dipropionate respectively in methanol. Linearity was obtained in concentration range of 0.1-0.6 �µg/ml and 5-30 �µg/ml respectively for Formoterol fumarate dihydrate and Beclomethasone dipropionate. The method is successfully applied to pharmaceutical formulation, with no interference from excipients. The proposed method is simple, accurate for routine simultaneous estimation of Formoterol fumarate dihydrate and Beclomethasone dipropionate....
A simple, accurate and precise U.V spectrophotometric method has been developed and validated for the simultaneous estimation of Febuxostat and Diclofenac Potassium in combined dosage form by using Acetonitrile. The absorption maxima of Febuxostat and Diclofenac Potassium were found to be 314nm and 282nm. Linearity ranges of Febuxostat and Diclofenac Potassium were found to be 10-100�µg/ml and 25-150�µg/ml with correlation coefficients (r2) of the regression equations greater than 0.999 in all cases respectively. LOD and LOQ for Febuxostat and Diclofenac Potassium were found to be 0.73ug/ml & 1.09ug/ml and 2.2ug/ml & 3.3ug/ml respectively. Results of assay and recovery studies were statistically evaluated for its accuracy and precision in all cases. According to the validation results performed as per ICH guidelines, the proposed method was found to be specific, accurate, precise and could be applied to the simultaneous quantitative analysis of Febuxostat and Diclofenac Potassium....
A simple, precise and reproducible method has been developed and validated for the estimation of Ondansetron hydrochloride in pharmaceutical dosage forms by RP-HPLC. The separation was achieved using INERTSIL C8 (250mm x 4.6mm, 5�µ particle size) in isocratic mode with mobile phase acetonitrile: water (60:40 v/v); pH was adjusted to 2.5 with 0.1% orthophosphoric acid at a flow rate of 1.0ml/min. Detection was carried out at 247nm using PDA detector. The retention time was found to be 3.56min. The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The method was validated according to ICH guidelines. The method was linear in the concentration range of 50-150 �µg/ml with a correlation coefficient of 0.999. The percentage recovery study of ondansetron hydrochloride was found to be 99.59-101.34% respectively. The proposed method can be used for routine analysis...
Miconazole is an imidazole antifungal drug which is available in the different pharmaceutical dosage forms through various routes of administration, such as oral, topical and systemic. The drug is a Broad-spectrum antifungal agent and it is used in the treatment of superficial or systemic fungal infections. This article reviews the current analytical methods for identification and quantitative determination of Miconazole in samples. The clinical and pharmaceutical analysis of this drug requires effective analytical procedures for quality control and pharmacodynamic and pharmacokinetic studies as well as stability study. An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the instrumental analytical methods which were developed and used for determination of Miconazole as single or combination with other drugs in bulk drugs, formulations and biological fluids have been reviewed. This review covers the time period from 1978 to 2012 during many analytical methods including spectrophotometric methods like UV and derivative; and chromatographic method including HPLC, HPTLC, GC and alternative method like Voltammetry, Potentiometric method were reported. The application of these methods for the determination of Miconazole in pharmaceutical formulations and biological samples has also been discussed....
Two simple and sensitive colorimetric methods have been developed for the quantitative estimation of Dapoxetine Hydrochloride (DPH) from Pharmaceutical tablet dosage form. Developed methods are based on the formation of chloroform extractable ion pair coloured complex of drug with Eosin Yellow (EY, Method A) and Methyl Blue\r\n (MB, Method B). The complex formed in method A and B showed maximum absorbance at 528.5 nm and 592.0 nm respectively. Linearity was obeyed in concentration range of 50-200 �µgm/ml and 200-1000 �µgm/ml of DPH for method A and B respectively. The results of analysis were validated statistically and by recovery studies....
Salicylic acid is a keratolytic and antiseptic agent,which is a key additive in many skin-care products for the treatment of acne, psoriasis, callouses, corns, keratosis pilaris and warts. Salicylic acid directly and irreversibly inhibits the activity of both types of cyclo-oxygenases (COX-1 and COX-2) to decrease the formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Salicylate may competitively inhibit prostaglandin formation.Topically it works by causing the cells of the epidermis to slough off more readily, preventing pores from clogging up, and allowing room for new cell growth.The clinical and pharmaceutical analysis of this drug requires effective analytical procedures for quality control and pharmacodynamic and pharmacokinetic studies as well as stability study. An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the instrumental analytical methods which were developed and used for determination of Salicylic acid as single or combination with other drugs in bulk drugs, formulations and biological fluids have been reviewed. This review covers 75 analytical methods including spectrophotometric methods like like UV and Derivative;Colorimetric methods; chromatographic method including HPLC,HPTLC,GC and miscellaneous method like voltammetry, spectrofluorometry, non-aqueous titration, capillary electrofluoroscence were reported. The application of these methods for the determination of Salicylic acid in pharmaceutical dosage forms and biological samples has also been discussed....
A simple and sensitive direct visible spectrophotometric method has been developed for the determination of Ropinirole hydrochloride in bulk and solid dosage forms. Ropinirole hydrochloride exhibits ?max at 441nm with 3-methtyl -2-benzothiazolinone hydrazone hydrochloride (MBTH) in presence of ferric chloride as oxidizing agent. The Beerâ��s law obeyed in the concentration range of 20-120�µg/ml with correlation coefficient of 0.995. The proposed method was validated as per ICH guideline....
Aim: An approach of forced degradation study was successfully applied for development and validation of stability indicating assay method for the simultaneous estimation and quantification of three anti-hypertensive drugs, viz., Olmesartan Medoxomil, Hydrochlorothiazide and Amlodipine Besylate in marketed formulation in presence of its degradation products. The method showed adequate separation of all three drugs from their associated degradation products. Materials and Methods: The separation was achieved on Hypersil BDS C18 column (250 x 4.6 mm id, 5 �µm particle size) using mobile phase of triethylamine buffer solution (at pH 3): acetonitrile (gradient program). The flow rate was 1 ml/min and detection was done at 236 nm on photodiode array detector. Comprehensive stress testing of all drugs was carried out according to the International Conference on Harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid hydrolysis, base hydrolysis, oxidation, dry heat, and photolysis to apply stress conditions. There were no other coeluting, interfering peaks from excipients, impurities, or degradation products due to variable stress conditions, and the method was specific for determination of all drugs in the presence of degradation products. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug Results: The retention time for Hydrochlorothiazide, Amlodipine besylate and Olmesartan medoxomil was 3.7 min, 7.0 min and 8.4 min respectively. The linearity of method was investigated in range of 20-60 �µg/ml (r2=0.9999) for Olmesartan medoxomil, 12.5-37.5 �µg/ml (r2=0.9998) for Hydrochlorothiazide and 5-15 �µg/ml (r2=0.9998) for Amlodipine besylate respectively. Validation results indicated that method shows satisfactory linearity, accuracy, precision, robustness and ruggedness. Conclusion: Degradation products produced in stress studies did not interfere with the detection of main drugs and henceforth this stability indicating method can also be successfully employed for simultaneous estimation of all drugs in commercial products....
A simple, precise, and accurate method was developed for the estimation of Tolperisone (TOL) and Paracetamol (PCM) in synthetic mixture using second order derivative spectrophotometry. Wavelengths selected for quantitation were 257.3 nm for Tolperisone (zero crossing point of Paracetamol) and 218.8 nm for Paracetamol (zero crossing point of Tolperisone). The method was validated with respect to linearity, accuracy, precision, limit of detection and limit of quantitation in accordance with the International Conference on Harmonisation (ICH) guidelines. Linearity was observed in concentration range of 2-14 �µg/ml for each Tolperisone and Paracetamol. The limit of detection and limit of quantitation were found to be 0.275 �µg/ ml and 0.883 �µg/ ml for Tolperisone and 0.126 �µg/ ml and 0.384 �µg/ ml for Paracetamol. The percentage recovery of Tolperisone and Paracetamol was found to be 99.53% and 99.39%, respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was precise. The method can be successfully employed for the simultaneous estimation of Tolperisone and Paracetamol in synthetic mixture....
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