DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND SIMVASTATIN
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 12
Abstract
A simple, precise and accurate method has been developed for simultaneous estimation of Sitagliptin phosphate and Simvastatin. The proposed RP-HPLC method utilises C18 G column (250 x 4.6mm, 5μm), mobile phase consisting of water and acetonitrile in the ratio of 30:70 (v/v) and UV detection at 236nm using a photodiode array detector. The stability indicating capability of the method was proved by subjecting the drugs to stress conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation as per ICH guidelines and resolution of the degradation products formed therein. The described method was linear over a range of 40 – 400 μg/ml for sitagliptin and 10 –50 μg/ml for simvastatin respectively. The method validation data showed excellent results for accuracy, precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies.
Authors and Affiliations
K. Y Kavitha , G Geetha , R Hariprasad
Keywords
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