Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules

Detalhes bibliográficos
Autor(a) principal: Mateus Araújo Castro e Souza
Data de Publicação: 2017
Outros Autores: Carlos Eduardo de Oliveira Pereira, Fernando Henrique Andrade Nogueira, Gerson Antônio Pianetti
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: http://hdl.handle.net/1843/43818
Resumo: A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.
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spelling 2022-07-29T21:33:26Z2022-07-29T21:33:26Z20175331810.1590/s2175-979020170003000411984-8250http://hdl.handle.net/1843/43818A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.Um método de HPLC indicador de estabilidade para determinação de cloridrato de diltiazem (DTZ) em comprimidos e cápsulas manipuladas foi desenvolvido e validado de acordo com as diretrizes brasileiras e da Conferência Internacional de Harmonização (ICH). A separação foi realizada em uma coluna analítica Purospher Star® C18 (150 x 4,6 mm i.d., tamanho de partícula de 5 µm, Merck Millipore). A fase móvel consistiu de uma solução aquosa de ácido trifluoroacético a 0,05% (v/v) e uma solução metanólica de ácido trifluoroacético a 0,05% (44:56, v/v). A vazão foi de 1,0 mL.min-1 com tempo de corrida de 14 minutos. A detecção de DTZ e produtos de degradação (DP) foi realizada em 240 nm, utilizando um detector de arranjo de diodos. O método mostrou-se linear, preciso, exato, seletivo e robusto, sendo adequado para estudos de estabilidade e análises de rotina de controle de qualidade de DTZ em comprimidos e cápsulas manipuladas.engUniversidade Federal de Minas GeraisUFMGBrasilFARMACIA - FACULDADE DE FARMACIABrazilian Journal of Pharmaceutical SciencesCloridrato de DiltiazemCápsulas ManipuladasCromatografia Líquida de Alta EficiênciaMétodo Indicador de EstabilidadeDevelopment and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsulesDesenvolvimento e validação de um método hplc indicador de estabilidade para determinação de cloridrato de diltiazem em comprimidos e cápsulas manipuladasinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://www.revistas.usp.br/bjps/article/view/134898Mateus Araújo Castro e SouzaCarlos Eduardo de Oliveira PereiraFernando Henrique Andrade NogueiraGerson Antônio Pianettiapplication/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/1843/43818/1/License.txtfa505098d172de0bc8864fc1287ffe22MD51ORIGINAL2017_Development and validation of a stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules.pdf2017_Development and validation of a stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules.pdfapplication/pdf668235https://repositorio.ufmg.br/bitstream/1843/43818/2/2017_Development%20and%20validation%20of%20a%20stability%20indicating%20HPLC%20method%20to%20determine%20diltiazem%20hydrochloride%20in%20tablets%20and%20compounded%20capsules.pdfe2976d3458cb9aa704adbbdf610201dfMD521843/438182022-07-29 18:33:26.538oai:repositorio.ufmg.br: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Repositório de PublicaçõesPUBhttps://repositorio.ufmg.br/oaiopendoar:2022-07-29T21:33:26Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false
dc.title.pt_BR.fl_str_mv Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
dc.title.alternative.pt_BR.fl_str_mv Desenvolvimento e validação de um método hplc indicador de estabilidade para determinação de cloridrato de diltiazem em comprimidos e cápsulas manipuladas
title Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
spellingShingle Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
Mateus Araújo Castro e Souza
Cloridrato de Diltiazem
Cápsulas Manipuladas
Cromatografia Líquida de Alta Eficiência
Método Indicador de Estabilidade
title_short Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
title_full Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
title_fullStr Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
title_full_unstemmed Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
title_sort Development and validation of a stability indicating hplc method to determine diltiazem hydrochloride in tablets and compounded capsules
author Mateus Araújo Castro e Souza
author_facet Mateus Araújo Castro e Souza
Carlos Eduardo de Oliveira Pereira
Fernando Henrique Andrade Nogueira
Gerson Antônio Pianetti
author_role author
author2 Carlos Eduardo de Oliveira Pereira
Fernando Henrique Andrade Nogueira
Gerson Antônio Pianetti
author2_role author
author
author
dc.contributor.author.fl_str_mv Mateus Araújo Castro e Souza
Carlos Eduardo de Oliveira Pereira
Fernando Henrique Andrade Nogueira
Gerson Antônio Pianetti
dc.subject.other.pt_BR.fl_str_mv Cloridrato de Diltiazem
Cápsulas Manipuladas
Cromatografia Líquida de Alta Eficiência
Método Indicador de Estabilidade
topic Cloridrato de Diltiazem
Cápsulas Manipuladas
Cromatografia Líquida de Alta Eficiência
Método Indicador de Estabilidade
description A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.
publishDate 2017
dc.date.issued.fl_str_mv 2017
dc.date.accessioned.fl_str_mv 2022-07-29T21:33:26Z
dc.date.available.fl_str_mv 2022-07-29T21:33:26Z
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/1843/43818
dc.identifier.doi.pt_BR.fl_str_mv 10.1590/s2175-97902017000300041
dc.identifier.issn.pt_BR.fl_str_mv 1984-8250
identifier_str_mv 10.1590/s2175-97902017000300041
1984-8250
url http://hdl.handle.net/1843/43818
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.pt_BR.fl_str_mv Brazilian Journal of Pharmaceutical Sciences
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 FARMACIA - FACULDADE DE FARMACIA
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
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