Development and validation of a RP-HPLC method for simultaneous determination of Dapagliflozin propanediol monohydrate and Bisoprolol fumarate in Pharmaceutical Dosage form

Abstract

The purpose of this study was to develop a new method for simultaneously determining the presence of Dapagliflozin propanediol monohydrate (DAPA) and Bisoprolol Fumarate (BISO) in a tablet formulation using reverse-phase high-performance liquid chromatography. The developed technique utilized an Inertsil ODS 3V (5 μm, 4.6*250mm) column with a 60:40 % v/v 0.2 % perchloric acid in water and acetonitrile, a flow rate of 1 ml/min, an injection volume of 10 µl and UV detection at 225 nm for both DAPA and BISO. The system suitability test, within acceptable limits, validates method reliability. Linearity calibration curves cover a concentration range for DAPA 20-150 µg/ml and BISO 10-75 µg/ml. Accuracy studies using the standard addition method produce recovery values between 99.49% and 99.52% for both drugs, demonstrating method accuracy. Precision studies (Repeatability and intermediate precision) reveals %RSD values constantly below 2 % highlighting method reproducibility. Robustness study promotes method reliability under small deliberate changes. The practicality of the method is demonstrated by its application to a pharmaceutical tablet formulation, which precisely quantifies DAPA (101.92%) and BISO (100.50%).