Analytical Method Development and Validation of Dapagliflozin and Vildagliptin using High Performance Liquid Chromatography

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Dapagliflozin and Vildagliptin in Tablet dosage form. Chromatogram was run through Agilent 250 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was Potassium dihydrogen orthophosphate buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 260.0 nm. Retention time of Vildagliptin  and Dapagliflozin were found to be 2.290 min and 2.896 min. %RSD of the Dapagliflozin and Vildagliptin were and found to be 0.5 and 0.4 respectively. %Recovery was obtained as 99.05% and 99.28% for Dapagliflozin and Vildagliptin respectively. LOD, LOQ values obtained from regression equations of Dapagliflozin and Vildagliptin were 0.01, 0.03 and 0.33, 1.0 respectively. Regression equation of Dapagliflozin is y = 32384x + 806.79, and y = 28076x + 6435.3 of Vildagliptin.