QUANTITATIVE DETERMINATION OF BEXAGLIFLOZIN IN TABLET FORMULATION AND BULK BY USING RP-HPLC.

Abstract

A new, accurate and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) as analytical method for the quantitative determination of Bexagliflozin was developed. For HPLC analysis, Reverse phase Chromotography method with photo diode array detector was chosen. The separation of the analyzed compound was conducted by means of a Discovery® C18 (5 μm particle size, L × I.D. 15 cm × 4.6 mm) analytical column, analyzed drugs were determined within 6.0 min using phosphate buffer (4.2ph_dipotassium hydrogen phosphate 0.01N) in water and Methanol in isocratic elution mode as mobile phase at a flow rate of 1.0 mL/min, Temperature was maintained at 30°C. Optimized wavelength selected was 220.0nm. Retention time of Bexagliflozin was found to be 2.167 min. the method was validated to fulfill International Conference on Harmonization (ICH) requirements and this validation included specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, and robustness. The calibration curve was linear over the concentration range from 5 to 30 μg/ml, The accuracy and precision of the method were within the acceptable limit of ±20% at the lower limit of quantitation and ±15% at other concentrations, all results were acceptable and this confirmed that the method is suitable for its intended use in routine quality control and assay of drugs.