Stability-indicating HPLC-DAD method for the determination of empagliflozin

Abstract

Background: A stability-indicating RP-HPLC method was developed and validated for the estimation of empa-gliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/ acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm absorption maxima. Results: Calibration curve plot was found within the range of 10-50 µg/mL. The coefficient of determination (R 2) was found to be 0.9990. Forced degradation studies were performed for the empagliflozin in various conditions, and the results were calculated as %RSD values and were found to be within the limits. Conclusion: The method was validated as per ICH guidelines with respect to all validation parameters.