RP- HPLC Method Development And Validation For Estimation Of Dapagliflozin In Tablet Formulation

Abstract

A novel, sensitive, suitable and robust strong-cation-exchange RP-HPLC technique was designed and evaluated towards the purpose
of identifying dapagliflozin in tablet formulation. The separation was performed with HPLC system containing UV- detector with
Openlab EZchrome software and kromasil C18, and methanol and water (75:25 % v/v) as mobile phase flowing at 1.0 ml/min. using
UV detector, the detection was performed at 223 nm. Dapagliflozin was eluted with retention time of 5.27 min. The results of
analysis have been evaluated with respect to stability, specificity, linearity, accuracy, precision (repeatability and intermediate
precision) and robustness. A simple, specific, rapid and reproducible technique has been designed in order to analyse dapagliflozin in
tablet formulation.