Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method

Detalhes bibliográficos
Autor(a) principal: Diego,Marta de
Data de Publicação: 2011
Outros Autores: Godoy,Gloria, Mennickent,Sigrid, Godoy,Ricardo
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Química Nova (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000300016
Resumo: The chemical stability of enalapril drug substance and tablets was studied by a stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under various conditions. Accelerated stability testing was carried out for different formulations of enalapril tablets. Chromatographic separation was achieved on a RP-18 column, using a mobile phase of methanol phosphate buffer at 1.0 mL min"1 and UV detection. Degradation of the drug substance was greater under hydrolytic conditions. After 180 days of accelerated stability testing most enalapril tablets showed more than 10% of degradation. Enalapril drug substance and tablets showed instability under stress and accelerated testing respectively, with possible implications on the therapeutic activity.
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spelling Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic methodenalaprilstabilityliquid chromatographyThe chemical stability of enalapril drug substance and tablets was studied by a stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under various conditions. Accelerated stability testing was carried out for different formulations of enalapril tablets. Chromatographic separation was achieved on a RP-18 column, using a mobile phase of methanol phosphate buffer at 1.0 mL min"1 and UV detection. Degradation of the drug substance was greater under hydrolytic conditions. After 180 days of accelerated stability testing most enalapril tablets showed more than 10% of degradation. Enalapril drug substance and tablets showed instability under stress and accelerated testing respectively, with possible implications on the therapeutic activity.Sociedade Brasileira de Química2011-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000300016Química Nova v.34 n.3 2011reponame:Química Nova (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.1590/S0100-40422011000300016info:eu-repo/semantics/openAccessDiego,Marta deGodoy,GloriaMennickent,SigridGodoy,Ricardoeng2011-04-12T00:00:00Zoai:scielo:S0100-40422011000300016Revistahttps://www.scielo.br/j/qn/ONGhttps://old.scielo.br/oai/scielo-oai.phpquimicanova@sbq.org.br1678-70640100-4042opendoar:2011-04-12T00:00Química Nova (Online) - Sociedade Brasileira de Química (SBQ)false
dc.title.none.fl_str_mv Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
title Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
spellingShingle Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
Diego,Marta de
enalapril
stability
liquid chromatography
title_short Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
title_full Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
title_fullStr Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
title_full_unstemmed Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
title_sort Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
author Diego,Marta de
author_facet Diego,Marta de
Godoy,Gloria
Mennickent,Sigrid
Godoy,Ricardo
author_role author
author2 Godoy,Gloria
Mennickent,Sigrid
Godoy,Ricardo
author2_role author
author
author
dc.contributor.author.fl_str_mv Diego,Marta de
Godoy,Gloria
Mennickent,Sigrid
Godoy,Ricardo
dc.subject.por.fl_str_mv enalapril
stability
liquid chromatography
topic enalapril
stability
liquid chromatography
description The chemical stability of enalapril drug substance and tablets was studied by a stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under various conditions. Accelerated stability testing was carried out for different formulations of enalapril tablets. Chromatographic separation was achieved on a RP-18 column, using a mobile phase of methanol phosphate buffer at 1.0 mL min"1 and UV detection. Degradation of the drug substance was greater under hydrolytic conditions. After 180 days of accelerated stability testing most enalapril tablets showed more than 10% of degradation. Enalapril drug substance and tablets showed instability under stress and accelerated testing respectively, with possible implications on the therapeutic activity.
publishDate 2011
dc.date.none.fl_str_mv 2011-01-01
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=S0100-40422011000300016
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000300016
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S0100-40422011000300016
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.34 n.3 2011
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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