Development and validation of a novel RP-HPLC method for estimation of bexagliflozin in pure and pharmaceutical formulation

In this research, a simple yet highly accurate, rapid, precise stability-indicating RP-HPLC method has been developed to quantify the concentration of Bexagliflozin in the pharmaceutical dosage form. The chromatographic elution has been performed on a reverse phase Discovery C₁₈ column (150mm × 4.6mm, I.D. 5μm) using a mobile phase comprised of 0.01N Na₂HPO₄: CH₂OH (55:45 v/v), adjusted to a pH of 4.0 using 0.1% orthophosphoric acid. The flow rate was 0.9 mL min^-1, and analysis was performed by a photodiode array detector at a wavelength of 220nm. The retention time of bexagliflozin was accurately measured to be 2.724 min. The drug demonstrated linearity across the 5-30μg mL^-1 range of concentrations (R² 0.999). The results showed that the LOD and LOQ had been 0.004μg mL^-1 and 0.011μg mL^-1, respectively. Forced degradation was carried out by following the guidelines of the ICH Q1A (R2), and the developed approach underwent validation in compliance with the ICH requirements. A novel stability-indicating RP-HPLC procedure has been developed for the accurate quantification of bexagliflozin. The suggested approach was effectively utilized to routinely analyze bexagliflozin in both its pure form and pharmaceutical formulations.