Development of Validated RP-HPLC Method for Estimation of Empagliflozin and Metformin in Combined Formulation

Aim: The aim of the present study include development of validated RP-HPLC method for estimation of Empagliflozin and Metformin in combined dosage form by using LC-MS compatible volatile mobile phase.

Methodology: Appropriate separation of drugs was achieved using C18 column as a stationary phase and Acetonitrile: Water (50: 50, v/v) at a flow rate 1mL/min as mobile phase. Detection was done at 230 nm.

Results: The Rt of Metformin and Empagliflozin was found to be 2.20 ± 0.02 min and 3.64 ± 0.02 min respectively. When the marketed formulation was analyzed by the developed method, the % drug contents were found to be 98.57 ± 1.28 and 99.86 ± 1.02 %w /w for Empagliflozin and Metformin, respectively. The method was found to be linear in a range of 11.25 – 56.25 μg/mL for Empagliflozin and 85 – 425 μg/mL for Metformin. Detection limit and quantitation limit were found to be 0.30 and 0.92 μg/mL for Empagliflozin and 1.12 and 3.36 μg/mL for Metformin, respectively. The accuracy and precision results were found to be near 100 % w/w for both the drugs. The method was also found to be robust and specific.

Conclusion: The developed RP-HPLC method was found to be linear, sensitive, accurate, precise, specific and robust for the analysis of Empagliflozin and Metformin in combined dosage form.