Development and validation of a dissolution test for empagliflozin in film-coated tablets

Joanna Wittckind Manoel; Gabriele Bordignon Primieri; Nadia Maria Volpato; Martin Steppe

doi:10.22456/2527-2616.112077

Authors

Joanna Wittckind Manoel Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul
Gabriele Bordignon Primieri Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul
Nadia Maria Volpato Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul
Martin Steppe Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul

DOI:

https://doi.org/10.22456/2527-2616.112077

Keywords:

Empagliflozin, Dissolution, Validation

Abstract

The present study proposes a validated dissolution method for empagliflozin (EMPA) in film coated tablets. A gradual in vitro dissolution profile for this formulation was obtained using 900 mL of hydrochloric acid 0.01 M at 37 °C ± 0.5 °C as dissolution medium and USP apparatus 2 (paddle) at 50 rpm. The dissolved percentage of EMPA was quantified by ultraviolet spectrophotometric method to obtain cost technique and produce little residual solvents. Validation parameter for dissolution methodology such as the specificity, linearity, accuracy and precision were evaluated according to the international guidelines, giving results within the acceptable range. The method is linear in the range of 1 - 40 µg/mL, precise, with RSD value less than 2.62%, accurate (mean recovery 106.97%) and robust. Therefore, since no official method has been described, the proposed dissolution conditions represent a relevant contribution to evaluate the dissolution profile of coated tablet containing 25 mg of EMPA.

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