Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate in Synthetic Mixture

A reliable and stability-indicating RP-HPLC method was successfully developed and validated for the simultaneous quantification of Bisoprolol Fumarate and Dapagliflozin Propanediol Monohydrate in a synthetic formulation, following ICH guidelines. Chromatographic separation was achieved using a mobile phase composed of 0.1% triethylamine and acetonitrile in a 66:33 ratio (v/v), adjusted to pH 3 with orthophosphoric acid. Analysis was conducted in isocratic mode on an Agilent Zorbax ODS C18 column (150 mm × 4.6 mm, 5 μm) with a flow rate of 1.5 ml/min and detection at 225 nm. Bisoprolol and Dapagliflozin were retained at 2.99 min and 9.35 min, respectively. System suitability parameters, such as theoretical plates, resolution, and tailing factor, met standard acceptance criteria. The method demonstrated excellent sensitivity with LOD values of 0.99 μg/ml for Bisoprolol and 3.02 μg/ml for Dapagliflozin, and LOQ values of 1.06 μg/ml and 3.23 μg/ml, respectively. Linearity was observed within the 5–15 μg/ml range, with correlation coefficients (r²) of 0.9995 and 0.9994. Accuracy studies showed recovery rates between 98.3–101.2% for Bisoprolol and 100.4–101.5% for Dapagliflozin. The method was validated under stress conditions including acidic, alkaline, oxidative, photolytic, and thermal environments, confirming its effectiveness as a stability-indicating analytical approach.