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Inventi Impact: Pharm Analysis & Quality Assurance
publication date: 2012/4/15

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND SIMVASTATIN IN BULK AND TABLET DOSAGE FORMS
                  Gebremriam Ketema*, D Gowris Sankar

ABSTRACT
A simple and rapid reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous determination of sitagliptin and simvastatin in bulk drug samples and formulations. The quantitative determination was carried out by using Luna C-18 (250 x 4.6mm, 5µ) column with a mobile phase consisting of a mixture of buffer: acetonitrile: methanol (40:35:25v/v), pH adjusted to 3.5 with orthophosphoric acid and Triethylamine. The mobile phase was filtered through a 0.45µ nylon filter, sonicated for 15 min and delivered at a flow rate of 1.0 ml/min. Analysis was performed at ambient temperature with detection at 254 nm. The calibration curves were linear (r2=0.998) over a concentration range from 50-500µg/ml for sitagliptin and (r2=0.999) over a concentration range from 20 -200 µg/ml for simvastatin. Limit of detection (LOD) and Limit of quantitation (LOQ) were 0.26 µg/ml and 0.77 µg/ml for sitagliptin and 0.06 µg/ml and 0.49 µg/ml for simvastatin respectively. The developed method was fast, accurate, precise and successfully applied to estimate the amount of sitagliptin and simvastatin in bulk sample and tablet dosage forms so it can be used for regular quality control of the drug.

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How to Cite This Article

Gebremriam Ketema*, D Gowris Sankar,  " DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND SIMVASTATIN IN BULK AND TABLET DOSAGE FORMS ",  Inventi Impact: Pharm Analysis & Quality Assurance ,  Vol. 2012 , Article ID- " Inventi:ppaqa/278/12 " 2012  [ cited 2014 Aug 22 ]  Available From  


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