A HIGHLY VALIDATED RP-HPLC METHOD DEVELOPMENT FOR THE SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN TABLET DOSAGE FORMS

A simple, accurate, precise method was developed for the simultaneous estimation of Dapagliflozin and Saxagliptin in Tablet dosage form. Chromatogram was run through Standard BDS C8 column (50 × 4.6 mm, 5m) The Mobile phase containing Potassium dihydrogen phosphate: Acetonitrile in the ratio 55:45, pH was adjusted to 3.8 with dilute orthophosphoric acid. The solution was pumped through the column at a flow rate of 1 ml/min. The column temperature was maintained at 30°C. Optimized wavelength selected was 210 nm. Retention time of Dapagliflozin and Saxagliptin were found to be 2.266 min and 2.805 min. % RSD of the Dapagliflozin and Saxagliptin were found to be 0.5 and 0.5 respectively. % Recovery was obtained as 98.98% and 98.72% for Dapagliflozin and Saxagliptin respectively. LOD, LOQ values obtained from regression equations of Dapagliflozin and Saxagliptin were 0.20, 0.60 and 0.26, 0.79 respectively. Regression equation of Dapagliflozin is y = 37377x + 89244, and y =12254x + 3122 of Saxagliptin. The retention times were decreased so that the run time also decreased. So the method developed was simple and economical that can be applied successfully for simultaneous estimation of both Dapagliflozin and Saxagliptin in bulk and combined tablet formulation.