World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF A RAPID RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS

Dhanush Ram Turkane*

ABSTRACT

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.

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