Method development and validation for simultaneous estimation of dapagliflozin and bisoprolol by using stability-indicating RPHPLC

Abstract

A fixed-dose combination of dapagliflozin and bisoprolol is used to treat type 2 diabetes mellitus and can also help to manage blood pressure and cardiovascular risks. The research article aims to develop and validate a stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of dapagliflozin propanediol monohydrate and bisoprolol fumarate. The separation is performed using a Kromasil 100 ODS column (250 mm × 4.6 mm, 5 μm), with a mobile phase consisting of 80:20 (v/v) methanol: water mixture adjusted to pH 3 with 0.1% formic acid, at a flow rate of 0.8 mL/min, and wavelength of 224 nm. The validation of the developed method was performed as per the ICH Q2 guideline. The medication underwent oxidation, photolysis, thermal degradation, acidic and alkaline hydrolysis. Separation of both the drugs takes place within 6 min. The developed method was linear from 5 to 25 μg/mL for both the drugs, and accurate as percentage recoveries ranged from 99.81 to 100.16% for dapagliflozin and 99.94 to 100.54% for bisoprolol. The results of precision were found within satisfactory limits. The results of the forced degradation investigation demonstrate that the approach is stability indicating since it can differentiate the peak of the active analyte from the degraded product. The suggested stabilityindicating RP-HPLC method is robust, specific, linear, accurate, and precise. This approach can therefore be used effectively for stability investigations and routine analysis.