Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms

Detalhes bibliográficos
Autor(a) principal: Reddy,Gosula Venkat Ram
Data de Publicação: 2011
Outros Autores: Reddy,Bobba Venkateswara, Haque,Syed Wasimul, Gautam,Haum Dutt, Kumar,Poonam, Kumar,Avvaru Praveen, Park,Jung Hag
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Química Nova (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000200015
Resumo: The present work describes a novel stability-indicating reversed-phase ultra performance liquid chromatography method for the separation and quantification of rosuvastatin (RSV) and its related impurities in the pharmaceutical dosage forms under forced degradation conditions. An unknown degradation impurity detected in the acid degradation was identified by using quadrupole time-of-flight mass spectrometry. The chromatographic separation was carried out on C-18 column (100 x 2.1 mm, 1.7 μm) using isocratic elution with methanol and 0.1% trifluoroacetic acid (50:50). The total run time was 12 min within which RSV as well as all related impurities and degradation products were separated. The developed method was validated for RSV and related impurities in pharmaceutical dosage forms.
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spelling Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage formsUPLC-QToF-MSrosuvastatin tabletsdegradation studyThe present work describes a novel stability-indicating reversed-phase ultra performance liquid chromatography method for the separation and quantification of rosuvastatin (RSV) and its related impurities in the pharmaceutical dosage forms under forced degradation conditions. An unknown degradation impurity detected in the acid degradation was identified by using quadrupole time-of-flight mass spectrometry. The chromatographic separation was carried out on C-18 column (100 x 2.1 mm, 1.7 μm) using isocratic elution with methanol and 0.1% trifluoroacetic acid (50:50). The total run time was 12 min within which RSV as well as all related impurities and degradation products were separated. The developed method was validated for RSV and related impurities in pharmaceutical dosage forms.Sociedade Brasileira de Química2011-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000200015Química Nova v.34 n.2 2011reponame:Química Nova (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.1590/S0100-40422011000200015info:eu-repo/semantics/openAccessReddy,Gosula Venkat RamReddy,Bobba VenkateswaraHaque,Syed WasimulGautam,Haum DuttKumar,PoonamKumar,Avvaru PraveenPark,Jung Hageng2011-03-14T00:00:00Zoai:scielo:S0100-40422011000200015Revistahttps://www.scielo.br/j/qn/ONGhttps://old.scielo.br/oai/scielo-oai.phpquimicanova@sbq.org.br1678-70640100-4042opendoar:2011-03-14T00:00Química Nova (Online) - Sociedade Brasileira de Química (SBQ)false
dc.title.none.fl_str_mv Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
title Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
spellingShingle Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
Reddy,Gosula Venkat Ram
UPLC-QToF-MS
rosuvastatin tablets
degradation study
title_short Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
title_full Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
title_fullStr Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
title_full_unstemmed Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
title_sort Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
author Reddy,Gosula Venkat Ram
author_facet Reddy,Gosula Venkat Ram
Reddy,Bobba Venkateswara
Haque,Syed Wasimul
Gautam,Haum Dutt
Kumar,Poonam
Kumar,Avvaru Praveen
Park,Jung Hag
author_role author
author2 Reddy,Bobba Venkateswara
Haque,Syed Wasimul
Gautam,Haum Dutt
Kumar,Poonam
Kumar,Avvaru Praveen
Park,Jung Hag
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Reddy,Gosula Venkat Ram
Reddy,Bobba Venkateswara
Haque,Syed Wasimul
Gautam,Haum Dutt
Kumar,Poonam
Kumar,Avvaru Praveen
Park,Jung Hag
dc.subject.por.fl_str_mv UPLC-QToF-MS
rosuvastatin tablets
degradation study
topic UPLC-QToF-MS
rosuvastatin tablets
degradation study
description The present work describes a novel stability-indicating reversed-phase ultra performance liquid chromatography method for the separation and quantification of rosuvastatin (RSV) and its related impurities in the pharmaceutical dosage forms under forced degradation conditions. An unknown degradation impurity detected in the acid degradation was identified by using quadrupole time-of-flight mass spectrometry. The chromatographic separation was carried out on C-18 column (100 x 2.1 mm, 1.7 μm) using isocratic elution with methanol and 0.1% trifluoroacetic acid (50:50). The total run time was 12 min within which RSV as well as all related impurities and degradation products were separated. The developed method was validated for RSV and related impurities in pharmaceutical dosage forms.
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=S0100-40422011000200015
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000200015
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S0100-40422011000200015
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.2 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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