Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Pharmaceutical Sciences |
Texto Completo: | https://www.revistas.usp.br/bjps/article/view/201160 |
Resumo: | The first method by micellar electrokinetic chromatography (MEKC) for the determination of empagliflozin in tablets was developed and validated following the ICH guidelines. The separation was achieved in a fused silica capillary with 50 µm x 40 cm (inner diameter x effective length) at 28 ºC, +28 kV voltage, hydrodynamic injection 4s (50 mBar), detection at 225 nm and paracetamol was the internal standard. The running electrolyte was a mixture of 20 mM tris(hydroxymethyl) aminomethane (pH 10) and 100 mM sodium dodecyl sulphate (1:1). Specificity was evaluated by the stress testing and the method was specific, with no interference of the degradation product. Linearity was observed in the range of 50 to 150 μg/mL (r=0.9999). The method showed adequate accuracy (recovery value=100.60±0.60%), precision (RSD values <2%) and robustness, which was evaluated by a full factorial design 23. Drug degradation kinetics was evaluated in alkaline andacidic conditions and first-order kinetic was observed in both conditions. The cytotoxicity of sample solutions degraded by UVA and UVC radiation, alkaline and acid media were studied as well. A similar cellular viability profile was observed with a slight decrease only in samples degraded by UVC radiation and basic medium. |
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Brazilian Journal of Pharmaceutical Sciences |
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Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samplesCapillary electrophoresis. Empagliflozin. Validation. Cellular viability. Degradation kinetics.The first method by micellar electrokinetic chromatography (MEKC) for the determination of empagliflozin in tablets was developed and validated following the ICH guidelines. The separation was achieved in a fused silica capillary with 50 µm x 40 cm (inner diameter x effective length) at 28 ºC, +28 kV voltage, hydrodynamic injection 4s (50 mBar), detection at 225 nm and paracetamol was the internal standard. The running electrolyte was a mixture of 20 mM tris(hydroxymethyl) aminomethane (pH 10) and 100 mM sodium dodecyl sulphate (1:1). Specificity was evaluated by the stress testing and the method was specific, with no interference of the degradation product. Linearity was observed in the range of 50 to 150 μg/mL (r=0.9999). The method showed adequate accuracy (recovery value=100.60±0.60%), precision (RSD values <2%) and robustness, which was evaluated by a full factorial design 23. Drug degradation kinetics was evaluated in alkaline andacidic conditions and first-order kinetic was observed in both conditions. The cytotoxicity of sample solutions degraded by UVA and UVC radiation, alkaline and acid media were studied as well. A similar cellular viability profile was observed with a slight decrease only in samples degraded by UVC radiation and basic medium.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2022-11-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/20116010.1590/s2175-97902020000418903Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021)Brazilian Journal of Pharmaceutical Sciences; v. 57 (2021)Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021)2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/201160/185305https://www.revistas.usp.br/bjps/article/view/201160/185304Copyright (c) 2022 Brazilian Journal of Pharmaceutical Scienceshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessTrindade Biscaino, PaulineChrist, Ana PaulaRubert Nogueira Librelotto, DanieleBueno Rolim, Clarice MadalenaHorn Adams, Andréa Inês 2022-08-17T19:43:14Zoai:revistas.usp.br:article/201160Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2022-08-17T19:43:14Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
title |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
spellingShingle |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples Trindade Biscaino, Pauline Capillary electrophoresis. Empagliflozin. Validation. Cellular viability. Degradation kinetics. |
title_short |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
title_full |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
title_fullStr |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
title_full_unstemmed |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
title_sort |
Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples |
author |
Trindade Biscaino, Pauline |
author_facet |
Trindade Biscaino, Pauline Christ, Ana Paula Rubert Nogueira Librelotto, Daniele Bueno Rolim, Clarice Madalena Horn Adams, Andréa Inês |
author_role |
author |
author2 |
Christ, Ana Paula Rubert Nogueira Librelotto, Daniele Bueno Rolim, Clarice Madalena Horn Adams, Andréa Inês |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Trindade Biscaino, Pauline Christ, Ana Paula Rubert Nogueira Librelotto, Daniele Bueno Rolim, Clarice Madalena Horn Adams, Andréa Inês |
dc.subject.por.fl_str_mv |
Capillary electrophoresis. Empagliflozin. Validation. Cellular viability. Degradation kinetics. |
topic |
Capillary electrophoresis. Empagliflozin. Validation. Cellular viability. Degradation kinetics. |
description |
The first method by micellar electrokinetic chromatography (MEKC) for the determination of empagliflozin in tablets was developed and validated following the ICH guidelines. The separation was achieved in a fused silica capillary with 50 µm x 40 cm (inner diameter x effective length) at 28 ºC, +28 kV voltage, hydrodynamic injection 4s (50 mBar), detection at 225 nm and paracetamol was the internal standard. The running electrolyte was a mixture of 20 mM tris(hydroxymethyl) aminomethane (pH 10) and 100 mM sodium dodecyl sulphate (1:1). Specificity was evaluated by the stress testing and the method was specific, with no interference of the degradation product. Linearity was observed in the range of 50 to 150 μg/mL (r=0.9999). The method showed adequate accuracy (recovery value=100.60±0.60%), precision (RSD values <2%) and robustness, which was evaluated by a full factorial design 23. Drug degradation kinetics was evaluated in alkaline andacidic conditions and first-order kinetic was observed in both conditions. The cytotoxicity of sample solutions degraded by UVA and UVC radiation, alkaline and acid media were studied as well. A similar cellular viability profile was observed with a slight decrease only in samples degraded by UVC radiation and basic medium. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-11-09 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/201160 10.1590/s2175-97902020000418903 |
url |
https://www.revistas.usp.br/bjps/article/view/201160 |
identifier_str_mv |
10.1590/s2175-97902020000418903 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/201160/185305 https://www.revistas.usp.br/bjps/article/view/201160/185304 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2022 Brazilian Journal of Pharmaceutical Sciences https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2022 Brazilian Journal of Pharmaceutical Sciences https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
dc.source.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021) Brazilian Journal of Pharmaceutical Sciences; v. 57 (2021) Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021) 2175-9790 1984-8250 reponame:Brazilian Journal of Pharmaceutical Sciences instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Brazilian Journal of Pharmaceutical Sciences |
collection |
Brazilian Journal of Pharmaceutical Sciences |
repository.name.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
bjps@usp.br||elizabeth.igne@gmail.com |
_version_ |
1787713372938043392 |