Development and Validation of RP-HPLC method for Simultaneous Determination of Vildagliptin and Metformin in Bulk and Formulation Dosage

Abstract

A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of Vildagliptin and Metformin in Tablet dosage form. The determination was performed by the using of two phases one is stationary phase it’s a Thermo hypersil ODS C18 column having 250 x 4.6mm 5μ, and another one is mobile phase containing 0.1M Potassium hydro phosphate and Acetonitrile at the ratio (60:40%v/v) Adjust the pH:7.0 by using Ortho phosphoric acid. The flow rate was 1ml/min and effluents were monitored at 263nm. The retention time of Metformin and Vildagliptin was 2.1min and 3.5min respectively and other replicate standard system suitability parameters are within the limit and uniform. Validation parameters those are selectivity, linearity (correlation co efficient is 1.000), recovery of Vildagliptin 99.66% and metformin 101.66 as per USP accuracy acceptance criteria is 97% to 103%, precision % RSD is less than 1 and also robustness results were uniform they were no marked changes so method is highly validated it use full for pharmaceutical analysis like Quality control , Stability and other studies.