A simple, rapid, precise, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Empagliflozin and Metformin Hydrochloride in pharmaceutical dosage forms. Chromatographic separation was achieved using a Hypersil ODS C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of acetonitrile and 20 mM ammonium formate buffer (pH 3.5) in the ratio of 45:55 (v/v). The mobile phase was delivered at a flow rate of 1.0 mL/min, and detection was carried out at 230 nm using a diode array detector. The retention times of Empagliflozin and Metformin Hydrochloride were found to be 5.418 min and 2.851 min, respectively. The method exhibited excellent linearity over concentration ranges of 2.5–25 µg/mL for Empagliflozin and 12.5–125 µg/mL for Metformin Hydrochloride, with correlation coefficients of 0.9994 and 0.9997, respectively. Accuracy studies showed recoveries ranging from 99.62% to 100.54% for Empagliflozin and 99.85% to 100.42% for Metformin Hydrochloride. The method demonstrated satisfactory precision, ruggedness, robustness, and sensitivity, with all validation parameters meeting ICH guideline requirements. The developed method was successfully applied to the assay of marketed tablet formulations, yielding assay values within acceptable limits. The results indicate that the proposed RP-HPLC method is suitable for routine quality control and quantitative analysis of Empagliflozin and Metformin Hydrochloride in pharmaceutical dosage forms.
Dhanush Ram Turkane* (Wed,) studied this question.