UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil

Detalhes bibliográficos
Autor(a) principal: Naialy Fernandes Araújo Reis
Data de Publicação: 2021
Outros Autores: 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
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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spelling 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
identifier_str_mv 00219665
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.none.fl_str_mv Journal of Chromatographic Science
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 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
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFMG
instname:Universidade Federal de Minas Gerais (UFMG)
instacron:UFMG
instname_str Universidade Federal de Minas Gerais (UFMG)
instacron_str UFMG
institution UFMG
reponame_str Repositório Institucional da UFMG
collection Repositório Institucional da UFMG
bitstream.url.fl_str_mv https://repositorio.ufmg.br/bitstream/1843/52327/1/License.txt
https://repositorio.ufmg.br/bitstream/1843/52327/2/UHPLC%20for%20quality%20evaluation%20of%20genuine%20and%20illegal%20medicines%20containing%20sildenafil%20citrate%20and%20tadalafil.pdf
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