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

dc.creatorNaialy Fernandes Araújo Reis
dc.creatorLuiz Felipe Gomes da Silva
dc.creatorMateus Araújo Castro e Souza
dc.creatorSílvia Ligório Fialho
dc.creatorCarolina Paula de Souza Moreira
dc.creatorMarcus Vinicius de Oliveira Andrade
dc.creatorWashington Xavier de Paula
dc.creatorMaria Beatriz de Abreu Glória
dc.creatorGerson Antônio Pianetti
dc.creatorChristian Fernandes
dc.date.accessioned2023-04-20T20:46:27Z
dc.date.accessioned2025-09-09T01:23:19Z
dc.date.available2023-04-20T20:46:27Z
dc.date.issued2021-01
dc.description.sponsorshipCNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
dc.description.sponsorshipFAPEMIG - Fundação de Amparo à Pesquisa do Estado de Minas Gerais
dc.description.sponsorshipCAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
dc.format.mimetypepdf
dc.identifier.doihttps://doi.org/10.1093/chromsci/bmaa073
dc.identifier.issn00219665
dc.identifier.urihttps://hdl.handle.net/1843/52327
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofJournal of Chromatographic Science
dc.rightsAcesso Aberto
dc.subjectFarmácia
dc.subjectMedicamentos
dc.subjectQualidade de medicamentos
dc.subjectCromatografia líquida
dc.subject.otherSeizure medicines
dc.subject.otherSildenafil
dc.subject.otherTadalafil
dc.subject.otherForced degradation
dc.subject.otherUHPLC-MS/MS
dc.titleUHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil
dc.typeArtigo de periódico
local.citation.epage39
local.citation.issue1
local.citation.spage30
local.citation.volume59
local.description.resumoOne 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.
local.publisher.countryBrasil
local.publisher.departmentFAR - DEPARTAMENTO DE ALIMENTOS
local.publisher.departmentFAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOS
local.publisher.initialsUFMG
local.url.externahttps://academic.oup.com/chromsci/article/59/1/30/5940794

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