Accelerated Stability Indicating LC Method for Simultaneous Quantification of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate

A combination of dapagliflozin propanediol monohydrate and bisoprolol fumarate was approved by a regulatory agency for the treatment of Type 2 diabetes mellitus in patients with hypertension. A simple reverse‐phase LC method was developed and validated for simultaneous quantification of dapagliflozin propanediol monohydrate and bisoprolol fumarate in bulk and marketed formulation. The optimized chromatographic condition includes Inertsil ODS 3 V (250 mm × 4.6 mm, 5 µm) as the stationary phase, gradient elution of mobile phase A containing 26 mM KH 2 PO 4 containing 0.4 mL/L triethylamine (pH 4.2 adjusted with dilute orthophosphoric acid) and acetonitrile in ratio of 90:10 v/v and mobile phase B containing 26 mM KH 2 PO 4 containing 0.4 mL/L triethylamine (pH 4.2 adjusted with dilute orthophosphoric acid) and acetonitrile in ratio of 25:75 v/v with flow rate of 1 mL/min. The analytical wavelength for detection of both drugs was 223 nm. The forced degradation study was also carried out to estimate the stability of drugs in bulk and formulation. The stress condition applied were acid, alkali, oxidative, thermal, and light. Dapagliflozin propanediol monohydrate was found to be stable and bisoprolol fumarate was degrading under oxidative and light conditions and remaining stable in other conditions applied. The proposed method was found to be linear in the concentration range of 2–24 µg/mL and 1–12 µg/mL with R 2 value of 0.9998 and 0.9984 for dapagliflozin propanediol monohydrate and bisoprolol fumarate, respectively. The optimized method was validated as per ICH Q2 (R2) guidelines and was found to be selective, specific, precise, accurate, and robust for quantification of both drugs.