Method development and validation for simultaneous estimation of dapagliflozin and vildagliptin in pharmaceutical dosage form by RP-HPLC

A simple, Accurate, precise method was developed for the simultaneous estimation of the Dapagliflozin and Vildagliptin in tablet dosage form. Chromatogram was run through Discovery C18 (4.6 × 150mm, 5μm). Mobile phase containing Acetonitrile: Na2hpo4 taken in the ratio 70:30 was pumped through column at a flow rate of 0.8 ml/min. Buffer used in this method Phosphate buffer and ph is adjusted to 5.2 by adding 0.1% Formic acid. Temperature was maintained at 30°C. Optimized wavelength selected was 220nm. Retention time of Dapagliflozin and Vildagliptin were found to be 2.307min and 2.865min. %RSD of the Dapagliflozin and Vildagliptin were and found to be 0.9 and 0.7 respectively. %Recovery was obtained as 100.41% and 99.94% for Dapagliflozin and Vildagliptin respectively. LOD, LOQ values obtained from regression equations of Dapagliflozin and Vildagliptin were 0.02, 0.07 and 0.24, 0.72 respectively. Regression equation of Dapagliflozin is y = 42540x + 1488.4. And y = 38485x + 2186.5 of Vildagliptin. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.