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

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...

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Main Authors: Joanna Wittckind Manoel, Gabriele Bordignon Primieri, Nadia Maria Volpato, Martin Steppe
Format: Article
Language:English
Published: Universidade Federal do Rio Grande do Sul 2021-12-01
Series:Drug Analytical Research
Online Access:https://seer.ufrgs.br/index.php/dar/article/view/112077
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author Joanna Wittckind Manoel
Gabriele Bordignon Primieri
Nadia Maria Volpato
Martin Steppe
author_facet Joanna Wittckind Manoel
Gabriele Bordignon Primieri
Nadia Maria Volpato
Martin Steppe
author_sort Joanna Wittckind Manoel
collection DOAJ
description 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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spelling doaj.art-c5636aba80874a869f82358c931291202024-03-06T18:15:00ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162021-12-0152Development and validation of a dissolution test for empagliflozin in film-coated tabletsJoanna Wittckind Manoel0Gabriele Bordignon Primieri1Nadia Maria Volpato2Martin Steppe3Universidade Federal do Rio Grande do SulUniversidade Federal do Rio Grande do SulUniversidade Federal do Rio Grande do SulUniversidade Federal do Rio Grande do Sul 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. https://seer.ufrgs.br/index.php/dar/article/view/112077
spellingShingle Joanna Wittckind Manoel
Gabriele Bordignon Primieri
Nadia Maria Volpato
Martin Steppe
Development and validation of a dissolution test for empagliflozin in film-coated tablets
Drug Analytical Research
title Development and validation of a dissolution test for empagliflozin in film-coated tablets
title_full Development and validation of a dissolution test for empagliflozin in film-coated tablets
title_fullStr Development and validation of a dissolution test for empagliflozin in film-coated tablets
title_full_unstemmed Development and validation of a dissolution test for empagliflozin in film-coated tablets
title_short Development and validation of a dissolution test for empagliflozin in film-coated tablets
title_sort development and validation of a dissolution test for empagliflozin in film coated tablets
url https://seer.ufrgs.br/index.php/dar/article/view/112077
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