UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFMG |
Texto Completo: | https://doi.org/10.1093/chromsci/bmaa073 http://hdl.handle.net/1843/52327 |
Resumo: | CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico |
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2023-04-20T20:46:27Z2023-04-20T20:46:27Z2021-015913039https://doi.org/10.1093/chromsci/bmaa07300219665http://hdl.handle.net/1843/52327CNPq - Conselho Nacional de Desenvolvimento Científico e TecnológicoFAPEMIG - Fundação de Amparo à Pesquisa do Estado de Minas GeraisCAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível SuperiorOne of the highest incidences of illegal drug products is related to phosphodiesterase-5 inhibitors, used in treatment of erectile dysfunction, including those containing sildenafil citrate and tadalafil. In this context, comprehensive evaluation of the quality of genuine and illegal medicines was performed. A simple and rapid ultra-high performance liquid chromatography (UHPLC-UV) method to quantify sildenafil and tadalafil in the presence of six degradation products was developed and validated. Sildenafil and tadalafil were submitted to forced degradation. The separation was carried out on a Kinetex C18 (50 × 2.1 mm; 1.7 μm) column with mobile phase composed of acetonitrile and aqueous triethylamine solution. The calibration curves were linear in the range of 14–126 μg mL−1 for sildenafil citrate and 4–36 μg mL−1 for tadalafil and the method proved to be selective, precise, accurate and robust. Sildenafil degraded in oxidative media, whereas tadalafil degraded in acidic, alkaline and oxidative environment. The chemical structures and the mechanisms for the formation of the main degradation products were proposed by UHPLC coupled to tandem mass spectrometry. The UHPLC-UV method was applied in the pharmaceutical analysis of genuine and seized medicines. Some of them did not meet quality standards, mainly due to contents below specifications and the large variation on contents between units within a batch.engUniversidade Federal de Minas GeraisUFMGBrasilFAR - DEPARTAMENTO DE ALIMENTOSFAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOSJournal of Chromatographic ScienceFarmáciaMedicamentosQualidade de medicamentosCromatografia líquidaSeizure medicinesSildenafilTadalafilForced degradationUHPLC-MS/MSUHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://academic.oup.com/chromsci/article/59/1/30/5940794Naialy Fernandes Araújo ReisLuiz Felipe Gomes da SilvaMateus Araújo Castro e SouzaSílvia Ligório FialhoCarolina Paula de Souza MoreiraMarcus Vinicius de Oliveira AndradeWashington Xavier de PaulaMaria Beatriz de Abreu GlóriaGerson Antônio PianettiChristian Fernandesapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; charset=utf-82042https://repositorio.ufmg.br/bitstream/1843/52327/1/License.txtfa505098d172de0bc8864fc1287ffe22MD51ORIGINALUHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil.pdfUHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil.pdfapplication/pdf870561https://repositorio.ufmg.br/bitstream/1843/52327/2/UHPLC%20for%20quality%20evaluation%20of%20genuine%20and%20illegal%20medicines%20containing%20sildenafil%20citrate%20and%20tadalafil.pdf092d632ac56c03d69ca1738fd1f5551aMD521843/523272023-04-20 17:59:31.493oai:repositorio.ufmg.br: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Repositório de PublicaçõesPUBhttps://repositorio.ufmg.br/oaiopendoar:2023-04-20T20:59:31Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false |
dc.title.pt_BR.fl_str_mv |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
title |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
spellingShingle |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil Naialy Fernandes Araújo Reis Seizure medicines Sildenafil Tadalafil Forced degradation UHPLC-MS/MS Farmácia Medicamentos Qualidade de medicamentos Cromatografia líquida |
title_short |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
title_full |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
title_fullStr |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
title_full_unstemmed |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
title_sort |
UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil |
author |
Naialy Fernandes Araújo Reis |
author_facet |
Naialy Fernandes Araújo Reis Luiz Felipe Gomes da Silva Mateus Araújo Castro e Souza Sílvia Ligório Fialho Carolina Paula de Souza Moreira Marcus Vinicius de Oliveira Andrade Washington Xavier de Paula Maria Beatriz de Abreu Glória Gerson Antônio Pianetti Christian Fernandes |
author_role |
author |
author2 |
Luiz Felipe Gomes da Silva Mateus Araújo Castro e Souza Sílvia Ligório Fialho Carolina Paula de Souza Moreira Marcus Vinicius de Oliveira Andrade Washington Xavier de Paula Maria Beatriz de Abreu Glória Gerson Antônio Pianetti Christian Fernandes |
author2_role |
author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Naialy Fernandes Araújo Reis Luiz Felipe Gomes da Silva Mateus Araújo Castro e Souza Sílvia Ligório Fialho Carolina Paula de Souza Moreira Marcus Vinicius de Oliveira Andrade Washington Xavier de Paula Maria Beatriz de Abreu Glória Gerson Antônio Pianetti Christian Fernandes |
dc.subject.por.fl_str_mv |
Seizure medicines Sildenafil Tadalafil Forced degradation UHPLC-MS/MS |
topic |
Seizure medicines Sildenafil Tadalafil Forced degradation UHPLC-MS/MS Farmácia Medicamentos Qualidade de medicamentos Cromatografia líquida |
dc.subject.other.pt_BR.fl_str_mv |
Farmácia Medicamentos Qualidade de medicamentos Cromatografia líquida |
description |
CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico |
publishDate |
2021 |
dc.date.issued.fl_str_mv |
2021-01 |
dc.date.accessioned.fl_str_mv |
2023-04-20T20:46:27Z |
dc.date.available.fl_str_mv |
2023-04-20T20:46:27Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/1843/52327 |
dc.identifier.doi.pt_BR.fl_str_mv |
https://doi.org/10.1093/chromsci/bmaa073 |
dc.identifier.issn.pt_BR.fl_str_mv |
00219665 |
url |
https://doi.org/10.1093/chromsci/bmaa073 http://hdl.handle.net/1843/52327 |
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00219665 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.none.fl_str_mv |
Journal of Chromatographic Science |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
dc.publisher.none.fl_str_mv |
Universidade Federal de Minas Gerais |
dc.publisher.initials.fl_str_mv |
UFMG |
dc.publisher.country.fl_str_mv |
Brasil |
dc.publisher.department.fl_str_mv |
FAR - DEPARTAMENTO DE ALIMENTOS FAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOS |
publisher.none.fl_str_mv |
Universidade Federal de Minas Gerais |
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reponame:Repositório Institucional da UFMG instname:Universidade Federal de Minas Gerais (UFMG) instacron:UFMG |
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Universidade Federal de Minas Gerais (UFMG) |
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UFMG |
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UFMG |
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Repositório Institucional da UFMG |
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Repositório Institucional da UFMG |
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