Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC

Abstract

Aim: To Perform Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin Tablet dosage form developed in a simple, Accurate, precise manner. Method: Agilent C18 150 x 4.6mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1.0 ml/min used for the development of chromatogram. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 260nm. Results and Conclusion: Retention time of Saxagliptin, Dapagliflozin and Metformin were found to be 2.253 min, 2.720 min, 3.276 min respectively. % RSD of the Saxagliptin, Dapagliflozin and Metformin were and found to be 0.8, 0.2 and 0.6. % Recovery was obtained as 99.60%, 100.07% and 99.95% for Saxagliptin, Dapagliflozin and Metformin respectively. LOD, LOQ values obtained from regression equations of Saxagliptin, Dapagliflozin and Metformin were 0.06, 0.12, 9.61 and 0.17, 0.36, 29.31 respectively. Regression equation of Saxagliptin is y = 40882x + 889.2, Dapagliflozin is y = 47904x + 3897 and Metformin is y = 4530.x + 35785. 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.