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dc.contributor.authorMartiny, Simonypt_BR
dc.contributor.authorWaszczuk, Mairiquept_BR
dc.contributor.authorKaiser, Samuelpt_BR
dc.contributor.authorNemitz, Marina Cardosopt_BR
dc.contributor.authorBassani, Valquiria Linckpt_BR
dc.date.accessioned2021-11-04T04:24:26Zpt_BR
dc.date.issued2020pt_BR
dc.identifier.issn2527-2616pt_BR
dc.identifier.urihttp://hdl.handle.net/10183/231541pt_BR
dc.description.abstractThe 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.en
dc.format.mimetypeapplication/pdfpt_BR
dc.language.isoengpt_BR
dc.relation.ispartofDrug analytical research. Porto Alegre (RS). Vol. 4, n. 1 (2020), p. 29-39pt_BR
dc.rightsOpen Accessen
dc.subjectFarmáciapt_BR
dc.subjectTrifolium pratenseen
dc.subjectIsoflavone aglyconesen
dc.subjectEstabilidade de medicamentospt_BR
dc.subjectHPLCen
dc.subjectTrifoliumpt_BR
dc.subjectStability-indicating methoden
dc.subjectValidationen
dc.titleStability-indicating HPLC method for isoflavones aglycones analysis from Trifolium pratense L. extractpt_BR
dc.typeArtigo de periódicopt_BR
dc.identifier.nrb001125139pt_BR
dc.type.originNacionalpt_BR


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