Bio-analytical Development and Validation of RP-HPLC Liquid Method for Quantification of Dapagliflozin Propanediol in Spiked Human Plasma

Abstract

The purpose of the present research was to develop a suitable simple and reproducible RP-HPLC method for a quantification of dapagliflozin propanediol in spiked human plasma samples. The liquidliquid extraction plasma spiked samples of dapagliflozin propanediol were analyzed by using a ODS C18 Prontosil column under isocratic conditions. The extracted plasma spiked samples were carried using methanol, acetonitrile and pH 5.6 acetate buffer in the ratio of 50:20:10 (v/v) with a flow rate of 0.9 mL/min. The detector response was monitored at 228 nm using UV detector. The method was validated as per the ICH guidelines for bio analytical method validation and all the validation parameters were found to be within the acceptance limit The plasma spiked samples shows stability at room temperature over a period of 48 h. Thus, this method would be employed for routine quantification of dapagliflozin in human plasma samples.