Stability-indicating RP-HPLC Method for the Simultaneous Quantitation of the Antihypertensive Agents Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate in a Combined Synthetic Mixture

An RP-HPLC method with stability-indicating capability was formulated to simultaneously quantify dapagliflozin propanediol monohydrate (DAPA) and bisoprolol fumarate (BSF) in a simulated combination. C18 column with dimensions of 250 × 4.6mm and particle size of 5µm was employed for the analysis, using a mobile phase of buffer (pH set to 4.0 with the aid of ortho phosphoric acid), methanol, acetonitrile in a volumetric ratio of 50:35:15 v/v/v. The system operated at a flow rate was maintained at 1.0µL/min, with detection monitored at 226nm via a PDA based detector. The retention times were observed at 3.032minutes for Bisoprolol fumarate and 4.634 minutes for Dapagliflozin. Excellent linearity was demonstrated across 10–60µg/mL for Bisoprolol fumarate (R² = 0.9964) and 20–120µg/mL for Dapagliflozin (R² = 0.9981). The method underwent validation in compliance with ICH Q2(R1) standards. Forced degradation studies showed higher sensitivity of Dapagliflozin towards acidic and oxidative conditions, while both drugs exhibited well-resolved degradation peaks under all tested stress conditions. This RP-HPLC method, proven to be stability-indicating and validated, is appropriate for the consistent analysis and stability evaluation of Dapagliflozin and Bisoprolol fumarate in pharmaceutical dosage forms.