Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/231541 |
Resumo: | The purpose of this study was to develop and validate a fast HPLC stability-indicating method for simultaneously quantifying the four main isoflavones in Trifolium pratense. Validation procedures followed the ICH and FDA requirements for complex matrices. The stability-indicating tests were performed by exposing the isoflavones to conditions of forced degradation and further analysis for verifying the formation of degradation products and their possible interferences in the HPLC analysis. The major isoflavones of Trifolium pratense proved to be stable against acid and oxidative media, thermodegradation, and photodegradation. However, they proved to be unstable in alkaline media, even for short periods of exposure like 2h. In this condition, in addition to the peaks corresponding to isoflavones, the HPLC analysis showed the presence of three additional peaks which were eluted at different retention times to the reference substances, without interfering in the quantification of the four analytes of interest, formononetin, biochanin A, daidzein, and genistein. The method was validated following ICH and FDA guidelines showing to be specific, linear, precise, accurate, and robust. This first report concerning a stability-indicating method revealed that the proposed HPLC method reliably quantify the isoflavones and separate them from the degradation products in a short time of analysis. |
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Martiny, SimonyWaszczuk, MairiqueKaiser, SamuelNemitz, Marina CardosoBassani, Valquiria Linck2021-11-04T04:24:26Z20202527-2616http://hdl.handle.net/10183/231541001125139The purpose of this study was to develop and validate a fast HPLC stability-indicating method for simultaneously quantifying the four main isoflavones in Trifolium pratense. Validation procedures followed the ICH and FDA requirements for complex matrices. The stability-indicating tests were performed by exposing the isoflavones to conditions of forced degradation and further analysis for verifying the formation of degradation products and their possible interferences in the HPLC analysis. The major isoflavones of Trifolium pratense proved to be stable against acid and oxidative media, thermodegradation, and photodegradation. However, they proved to be unstable in alkaline media, even for short periods of exposure like 2h. In this condition, in addition to the peaks corresponding to isoflavones, the HPLC analysis showed the presence of three additional peaks which were eluted at different retention times to the reference substances, without interfering in the quantification of the four analytes of interest, formononetin, biochanin A, daidzein, and genistein. The method was validated following ICH and FDA guidelines showing to be specific, linear, precise, accurate, and robust. This first report concerning a stability-indicating method revealed that the proposed HPLC method reliably quantify the isoflavones and separate them from the degradation products in a short time of analysis.application/pdfengDrug analytical research. Porto Alegre (RS). Vol. 4, n. 1 (2020), p. 29-39FarmáciaEstabilidade de medicamentosTrifoliumTrifolium pratenseIsoflavone aglyconesHPLCStability-indicating methodValidationStability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extractinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/otherinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001125139.pdf.txt001125139.pdf.txtExtracted Texttext/plain40670http://www.lume.ufrgs.br/bitstream/10183/231541/2/001125139.pdf.txt52614b6dbe2ab35a4d000a37713f92e8MD52ORIGINAL001125139.pdfTexto completo (inglês)application/pdf850295http://www.lume.ufrgs.br/bitstream/10183/231541/1/001125139.pdfcf6be20710dfe332537664ae1f1f93feMD5110183/2315412021-11-20 06:11:41.548202oai:www.lume.ufrgs.br:10183/231541Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2021-11-20T08:11:41Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
title |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
spellingShingle |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract Martiny, Simony Farmácia Estabilidade de medicamentos Trifolium Trifolium pratense Isoflavone aglycones HPLC Stability-indicating method Validation |
title_short |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
title_full |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
title_fullStr |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
title_full_unstemmed |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
title_sort |
Stability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extract |
author |
Martiny, Simony |
author_facet |
Martiny, Simony Waszczuk, Mairique Kaiser, Samuel Nemitz, Marina Cardoso Bassani, Valquiria Linck |
author_role |
author |
author2 |
Waszczuk, Mairique Kaiser, Samuel Nemitz, Marina Cardoso Bassani, Valquiria Linck |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Martiny, Simony Waszczuk, Mairique Kaiser, Samuel Nemitz, Marina Cardoso Bassani, Valquiria Linck |
dc.subject.por.fl_str_mv |
Farmácia Estabilidade de medicamentos Trifolium |
topic |
Farmácia Estabilidade de medicamentos Trifolium Trifolium pratense Isoflavone aglycones HPLC Stability-indicating method Validation |
dc.subject.eng.fl_str_mv |
Trifolium pratense Isoflavone aglycones HPLC Stability-indicating method Validation |
description |
The purpose of this study was to develop and validate a fast HPLC stability-indicating method for simultaneously quantifying the four main isoflavones in Trifolium pratense. Validation procedures followed the ICH and FDA requirements for complex matrices. The stability-indicating tests were performed by exposing the isoflavones to conditions of forced degradation and further analysis for verifying the formation of degradation products and their possible interferences in the HPLC analysis. The major isoflavones of Trifolium pratense proved to be stable against acid and oxidative media, thermodegradation, and photodegradation. However, they proved to be unstable in alkaline media, even for short periods of exposure like 2h. In this condition, in addition to the peaks corresponding to isoflavones, the HPLC analysis showed the presence of three additional peaks which were eluted at different retention times to the reference substances, without interfering in the quantification of the four analytes of interest, formononetin, biochanin A, daidzein, and genistein. The method was validated following ICH and FDA guidelines showing to be specific, linear, precise, accurate, and robust. This first report concerning a stability-indicating method revealed that the proposed HPLC method reliably quantify the isoflavones and separate them from the degradation products in a short time of analysis. |
publishDate |
2020 |
dc.date.issued.fl_str_mv |
2020 |
dc.date.accessioned.fl_str_mv |
2021-11-04T04:24:26Z |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/other |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10183/231541 |
dc.identifier.issn.pt_BR.fl_str_mv |
2527-2616 |
dc.identifier.nrb.pt_BR.fl_str_mv |
001125139 |
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2527-2616 001125139 |
url |
http://hdl.handle.net/10183/231541 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.pt_BR.fl_str_mv |
Drug analytical research. Porto Alegre (RS). Vol. 4, n. 1 (2020), p. 29-39 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
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