Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules

Detalhes bibliográficos
Autor(a) principal: Mendonça, Taciane Ferreira
Data de Publicação: 2011
Outros Autores: Barros, Eliézer Giannini de, Pereira, Gislaine Ribeiro, Araújo, Magali Benjamim de, Bonfilio, Rudy [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1590/S0100-40422011000300027
http://hdl.handle.net/11449/7956
Resumo: This work describes the development and validation of a dissolution test for 60 mg of diltiazem hydrochloride in immediate release capsules. The best dissolution in vitro profile was achieved using potassium phosphate buffer at pH 6.8 as the dissolution medium and paddle as the apparatus at 50 rpm. The drug concentrations in the dissolution media were determined by UV spectrophotometry and HPLC and a statistical analysis revealed that there were significant differences between HPLC and spectrophotometry. This study illustrates the importance of an official method for the dissolution test, since there is no official monograph for diltiazem hydrochloride in capsules.
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spelling Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsulesdissolutionhigh performance liquid chromatographyspectrophotometryThis work describes the development and validation of a dissolution test for 60 mg of diltiazem hydrochloride in immediate release capsules. The best dissolution in vitro profile was achieved using potassium phosphate buffer at pH 6.8 as the dissolution medium and paddle as the apparatus at 50 rpm. The drug concentrations in the dissolution media were determined by UV spectrophotometry and HPLC and a statistical analysis revealed that there were significant differences between HPLC and spectrophotometry. This study illustrates the importance of an official method for the dissolution test, since there is no official monograph for diltiazem hydrochloride in capsules.Center of Pharmaceutical Equivalence - Nucleus Quality ControlFundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Universidade Federal de Alfenas Centro de Equivalência Farmacêutica do Núcleo Controle de Qualidade Departamento de FarmáciaUniversidade Estadual Paulista Faculdade de Ciências Farmacêuticas Departamento de Fármacos e MedicamentosUniversidade Estadual Paulista Faculdade de Ciências Farmacêuticas Departamento de Fármacos e MedicamentosSociedade Brasileira de QuímicaUniversidade Federal de Alfenas (UNIFAL)Universidade Estadual Paulista (Unesp)Mendonça, Taciane FerreiraBarros, Eliézer Giannini dePereira, Gislaine RibeiroAraújo, Magali Benjamim deBonfilio, Rudy [UNESP]2014-05-20T13:25:09Z2014-05-20T13:25:09Z2011-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article520-526application/pdfhttp://dx.doi.org/10.1590/S0100-40422011000300027Química Nova. Sociedade Brasileira de Química, v. 34, n. 3, p. 520-526, 2011.0100-4042http://hdl.handle.net/11449/795610.1590/S0100-40422011000300027S0100-40422011000300027WOS:000289857500027S0100-40422011000300027.pdfSciELOreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengQuímica Nova0.6460,255info:eu-repo/semantics/openAccess2024-06-24T13:46:12Zoai:repositorio.unesp.br:11449/7956Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestrepositoriounesp@unesp.bropendoar:29462024-06-24T13:46:12Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
title Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
spellingShingle Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
Mendonça, Taciane Ferreira
dissolution
high performance liquid chromatography
spectrophotometry
title_short Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
title_full Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
title_fullStr Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
title_full_unstemmed Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
title_sort Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
author Mendonça, Taciane Ferreira
author_facet Mendonça, Taciane Ferreira
Barros, Eliézer Giannini de
Pereira, Gislaine Ribeiro
Araújo, Magali Benjamim de
Bonfilio, Rudy [UNESP]
author_role author
author2 Barros, Eliézer Giannini de
Pereira, Gislaine Ribeiro
Araújo, Magali Benjamim de
Bonfilio, Rudy [UNESP]
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Universidade Federal de Alfenas (UNIFAL)
Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Mendonça, Taciane Ferreira
Barros, Eliézer Giannini de
Pereira, Gislaine Ribeiro
Araújo, Magali Benjamim de
Bonfilio, Rudy [UNESP]
dc.subject.por.fl_str_mv dissolution
high performance liquid chromatography
spectrophotometry
topic dissolution
high performance liquid chromatography
spectrophotometry
description This work describes the development and validation of a dissolution test for 60 mg of diltiazem hydrochloride in immediate release capsules. The best dissolution in vitro profile was achieved using potassium phosphate buffer at pH 6.8 as the dissolution medium and paddle as the apparatus at 50 rpm. The drug concentrations in the dissolution media were determined by UV spectrophotometry and HPLC and a statistical analysis revealed that there were significant differences between HPLC and spectrophotometry. This study illustrates the importance of an official method for the dissolution test, since there is no official monograph for diltiazem hydrochloride in capsules.
publishDate 2011
dc.date.none.fl_str_mv 2011-01-01
2014-05-20T13:25:09Z
2014-05-20T13:25:09Z
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://dx.doi.org/10.1590/S0100-40422011000300027
Química Nova. Sociedade Brasileira de Química, v. 34, n. 3, p. 520-526, 2011.
0100-4042
http://hdl.handle.net/11449/7956
10.1590/S0100-40422011000300027
S0100-40422011000300027
WOS:000289857500027
S0100-40422011000300027.pdf
url http://dx.doi.org/10.1590/S0100-40422011000300027
http://hdl.handle.net/11449/7956
identifier_str_mv Química Nova. Sociedade Brasileira de Química, v. 34, n. 3, p. 520-526, 2011.
0100-4042
10.1590/S0100-40422011000300027
S0100-40422011000300027
WOS:000289857500027
S0100-40422011000300027.pdf
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Química Nova
0.646
0,255
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 520-526
application/pdf
dc.publisher.none.fl_str_mv Sociedade Brasileira de Química
publisher.none.fl_str_mv Sociedade Brasileira de Química
dc.source.none.fl_str_mv SciELO
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv repositoriounesp@unesp.br
_version_ 1826304349391814656

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