Diode Array Detector Based RP-UPLC Method for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Metformin

Abstract

A simple, rapid, accurate, precise, and reproducible diode array detector-based RP-UPLC method for simultaneous estimation of dapagliflozin propanediol monohydrate and metformin hydrochloride in bulk and tablet dosage form has been developed and validated. The chromatographic analysis was carried out using Acquity UPLC HSS T3 C18 (50 × 2.1mm, 1.8μm) column with a mobile phase consisting of orthophosphoric acid (pH 3.00) and acetonitrile (55:45% V/V) in the isocratic mode, at a flow rate of 0.2mL/min, and eluents were the simultaneous measurement of dapagliflozin propanediol monohydrate and metformin hydrochloride in bulk and tablet dosage form using a diode array detector-based RP-UPLC technique has been developed and validated. The chromatographic analysis was carried out using an Acquity UPLC HSS T3 C18 (50 2.1mm, 1.8 m) column and an orthophosphoric acid (pH 3.00) and acetonitrile (55:45% V/V) mobile phase in the isocratic mode.at a flow rate of 0.2mL/min. Eluents were measured at 222nm. Metformin hydrochloride and dapagliflozin propanediol monohydrate were shown to have retention times of 0.845 minutes and 1.889 minutes, respectively. The linearity was established in the range of 5-15μg/mL for dapagliflozin propanediol monohydrate and 250-750μg/mL for metformin hydrochloride, which had a regression coefficient (r2) greater than 0.999. The % Recovery was found to be 98.77% - 99.57% and 99.15% -101.2% for dapagliflozin propanediol monohydrate and metformin hydrochloride respectively. In a short period,a larger number of samplescan be analyzed due to their short retention time and, therefore, will be economical for routine analysis in the pharmaceutical industry.