Analytical Method Development and Validation of RP-HPLC For Estimation of Remogliflozin Etabonate in Bulk and Pharmaceutical Dosage Form

Abstract

A straightforward, creative, and selective reverse phase-high performance liquid chromatography (RP-HPLC) method that has been developed and optimized can be used to quantify remogliflozin etabonate (RMZ) in both bulk and dose forms. Phenomenex C18, 250 mm X 4.6 mm, 5 µm, was used as the stationary phase for the analysis at a flow rate of 1.2 mL/min, injection volume of 20 µl, run time of 8 min, and detection wavelength of 228 nm. The mobile phase was a mixture of 0.1% trifluoroacetic acid and methanol in a ratio of 30:70 v/v. Remogliflozin Etabonate Retention Time was evaluated by the analytical method at 3.7 minutes. To evaluate the linearity of the method, analyte concentration was measured throughout a range of ug/ml to 90 ug/ml, and area was plotted as a function of analyte concentration. For 50% to 150%, the individual recovery ranges from 95.0% to 105.0%, while the mean recovery ranges from 98.0% to 102.0%. The detection wavelength and flow rate were adjusted by ±2 nm and ±0.1 ml/min, respectively, for robustness. With a correlation coefficient (r2) of 0.9998, the approach was determined to be linear. With the right settings, the approach was also shown to be reliable and accurate.