Future Journal of Pharmaceutical Sciences (Aug 2021)

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

  • Shilpi Pathak,
  • Pradeep Mishra

DOI
https://doi.org/10.1186/s43094-021-00329-w
Journal volume & issue
Vol. 7, no. 1
pp. 1 – 8

Abstract

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Abstract Background A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin 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.

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