Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms

Detalhes bibliográficos
Autor(a) principal: Dalmora,Sérgio Luiz
Data de Publicação: 2010
Outros Autores: Nogueira,Daniele Rubert, Calegari,Guilherme Zanini, Bergamo,Ana Cláudia, Stamm,Fernanda Pavani
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Química Nova (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422010000500028
Resumo: A dissolution test for in vitro evaluation of tablet dosage forms containing 10 mg of rupatadine was developed and validated by RP-LC. A discriminatory dissolution method was established using apparatus paddle at a stirring rate of 50 rpm with 900 mL of deaerated 0.01 M hydrochloric acid. The proposed method was validated yielding acceptable results for the parameters evaluated, and was applied for the quality control analysis of rupatadine tablets, and to evaluate the formulation during an accelerated stability study. Moreover, quantitative analyses were also performed, to compare the applicability of the RP-LC and the LC-MS/MS methods.
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spelling Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage formsrupatadinedissolution testRP-LCA dissolution test for in vitro evaluation of tablet dosage forms containing 10 mg of rupatadine was developed and validated by RP-LC. A discriminatory dissolution method was established using apparatus paddle at a stirring rate of 50 rpm with 900 mL of deaerated 0.01 M hydrochloric acid. The proposed method was validated yielding acceptable results for the parameters evaluated, and was applied for the quality control analysis of rupatadine tablets, and to evaluate the formulation during an accelerated stability study. Moreover, quantitative analyses were also performed, to compare the applicability of the RP-LC and the LC-MS/MS methods.Sociedade Brasileira de Química2010-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422010000500028Química Nova v.33 n.5 2010reponame:Química Nova (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.1590/S0100-40422010000500028info:eu-repo/semantics/openAccessDalmora,Sérgio LuizNogueira,Daniele RubertCalegari,Guilherme ZaniniBergamo,Ana CláudiaStamm,Fernanda Pavanieng2010-07-23T00:00:00Zoai:scielo:S0100-40422010000500028Revistahttps://www.scielo.br/j/qn/ONGhttps://old.scielo.br/oai/scielo-oai.phpquimicanova@sbq.org.br1678-70640100-4042opendoar:2010-07-23T00:00Química Nova (Online) - Sociedade Brasileira de Química (SBQ)false
dc.title.none.fl_str_mv Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
title Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
spellingShingle Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
Dalmora,Sérgio Luiz
rupatadine
dissolution test
RP-LC
title_short Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
title_full Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
title_fullStr Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
title_full_unstemmed Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
title_sort Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms
author Dalmora,Sérgio Luiz
author_facet Dalmora,Sérgio Luiz
Nogueira,Daniele Rubert
Calegari,Guilherme Zanini
Bergamo,Ana Cláudia
Stamm,Fernanda Pavani
author_role author
author2 Nogueira,Daniele Rubert
Calegari,Guilherme Zanini
Bergamo,Ana Cláudia
Stamm,Fernanda Pavani
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Dalmora,Sérgio Luiz
Nogueira,Daniele Rubert
Calegari,Guilherme Zanini
Bergamo,Ana Cláudia
Stamm,Fernanda Pavani
dc.subject.por.fl_str_mv rupatadine
dissolution test
RP-LC
topic rupatadine
dissolution test
RP-LC
description A dissolution test for in vitro evaluation of tablet dosage forms containing 10 mg of rupatadine was developed and validated by RP-LC. A discriminatory dissolution method was established using apparatus paddle at a stirring rate of 50 rpm with 900 mL of deaerated 0.01 M hydrochloric acid. The proposed method was validated yielding acceptable results for the parameters evaluated, and was applied for the quality control analysis of rupatadine tablets, and to evaluate the formulation during an accelerated stability study. Moreover, quantitative analyses were also performed, to compare the applicability of the RP-LC and the LC-MS/MS methods.
publishDate 2010
dc.date.none.fl_str_mv 2010-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422010000500028
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422010000500028
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S0100-40422010000500028
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
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 Química Nova v.33 n.5 2010
reponame:Química Nova (Online)
instname:Sociedade Brasileira de Química (SBQ)
instacron:SBQ
instname_str Sociedade Brasileira de Química (SBQ)
instacron_str SBQ
institution SBQ
reponame_str Química Nova (Online)
collection Química Nova (Online)
repository.name.fl_str_mv Química Nova (Online) - Sociedade Brasileira de Química (SBQ)
repository.mail.fl_str_mv quimicanova@sbq.org.br
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