Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND METFORMIN IN BULK AND IN SYNTHETIC MIXTURE

Afshan Urooj*, P. Shyam Sundar, R. Vasanthi, M. Alagar Raja, K. Rajeswar Dutt, K. N. V. Rao and H. Ramana

ABSTRACT

A simple, accurate and precise reverse phase high performance liquid chromatography method has been developed for simultaneous estimation of Metformin and Dapagliflozin in bulk and synthetic mixture. The determination was carried out by using HPLC of waters (Model: Alliance 2695) with Phenomenex Luna C18 (4.6mm I.D. × 250mm, 5μm) column was used for chromatographic separation. It contains waters injector and PDA detector (Deuterium). Mobile phase consists of Acetonitrile: Water (75:25% v/v) and flow rate adjusted was 1ml/min. Wavelength selected for detection was 285nm and
injection volume was 10 μl. By using the developed method, retention time of Metformin and Dapagliflozin was found to be 3.2min and 5.4min respectively. The method has been validated for linearity, accuracy and precision. Linearity of Metformin and Dapagliflozin were in the range of 20–100μg/ml and 10–50μg/ml respectively. The percentage recoveries obtained for Metformin and Dapagliflozin were found to be in range of 99.3 – 99.6%. LOD and LOQ were found to be 5.0μg/ml and 15.2μg/ml for Metformin 3.7 and 11.4μg/ml for Dapagliflozin. Results of validation parameters demonstrated that the analytical procedures is suitable for its intended purpose and meets the criteria defined in ICH Q2R1.

Keywords: Metformin, Dapagliflozin, Simultaneous Estimation, RP-HPLC.