Validated RP-HPLC Method for the Estimation of Simvastatin and Sitagliptin
Journal Title: Scholars Academic Journal of Pharmacy - Year 2014, Vol 3, Issue 3
Abstract
A simple, sensitive, rapid, economic, robust RP-HPLC method was developed for the estimation of Sitagliptin-Simvastatin in Pure and Tablet dosage forms. An Agilent C8 Column (250 x 4.6 mm, 5µ) was used with a mobile phase containing a mixture of Methanol and water in the ratio of 25:75. The procedure was carried out at pH-2.9 and TEA was used as the Ion pairing agent. The flow rate was maintained at 1.0 ml/min. results were determined at 266 nm with fixed wavelength PDA detector. The linearity for Sitagliptin was found between 20-120 µg/ml and between 10-50 µg/ml for Simvastatin. The retention times were found as 3.227 and 15.760 for Sitagliptin and Simvastatin respectively. Validation parameters like Precision, Accuracy, Robustness and System suitability parameters were determined and examined by applying validated parameters. Keywords: Sitagliptin, Simvastatin, Method development, Validation, RP-HPLC
Authors and Affiliations
Sujani PV, Y Padamanabha Reddy, N Devanna ,, SS Phanindra ,
Keywords
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