A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase

Detalhes bibliográficos
Autor(a) principal: Patil,Kiran
Data de Publicação: 2012
Outros Autores: Rane,Vipul, Yeole,Ravindra, Shinde,Devanand
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Journal of the Brazilian Chemical Society (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532012000600008
Resumo: A simple, rapid, isocratic, normal phase chiral HPLC method was developed and validated for the enantiomeric separation of repaglinide, (S)-(+)-2-ethoxy-4-N [1-(2-piperidinophenyl)-3-methyl-1-butyl] aminocarbonylmethyl] benzoic acid, an antidiabetic drug substance. The enantiomers of repaglinide were resolved on a Chiralpak IA (immobilized amylose based stationary phase) column using a mobile phase consisting of n-hexane:ethanol:trifluoroacetic acid (80:20:0.2, v/v/v) at a flow rate of 1.0 mL min-1. The resolution between both enantiomers was greater than 2 in the optimized method. The developed method was extensively validated and proved to be robust, enantioselective, accurate, precise, and suitable for quantitative determination of (R)-enantiomer in bulk drug substance and product.
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spelling A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phaserepaglinideenantiomeric puritychiral LCmethod validationA simple, rapid, isocratic, normal phase chiral HPLC method was developed and validated for the enantiomeric separation of repaglinide, (S)-(+)-2-ethoxy-4-N [1-(2-piperidinophenyl)-3-methyl-1-butyl] aminocarbonylmethyl] benzoic acid, an antidiabetic drug substance. The enantiomers of repaglinide were resolved on a Chiralpak IA (immobilized amylose based stationary phase) column using a mobile phase consisting of n-hexane:ethanol:trifluoroacetic acid (80:20:0.2, v/v/v) at a flow rate of 1.0 mL min-1. The resolution between both enantiomers was greater than 2 in the optimized method. The developed method was extensively validated and proved to be robust, enantioselective, accurate, precise, and suitable for quantitative determination of (R)-enantiomer in bulk drug substance and product.Sociedade Brasileira de Química2012-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532012000600008Journal of the Brazilian Chemical Society v.23 n.6 2012reponame:Journal of the Brazilian Chemical Society (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.1590/S0103-50532012000600008info:eu-repo/semantics/openAccessPatil,KiranRane,VipulYeole,RavindraShinde,Devanandeng2012-07-13T00:00:00Zoai:scielo:S0103-50532012000600008Revistahttp://jbcs.sbq.org.brONGhttps://old.scielo.br/oai/scielo-oai.php||office@jbcs.sbq.org.br1678-47900103-5053opendoar:2012-07-13T00:00Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ)false
dc.title.none.fl_str_mv A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
title A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
spellingShingle A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
Patil,Kiran
repaglinide
enantiomeric purity
chiral LC
method validation
title_short A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
title_full A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
title_fullStr A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
title_full_unstemmed A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
title_sort A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
author Patil,Kiran
author_facet Patil,Kiran
Rane,Vipul
Yeole,Ravindra
Shinde,Devanand
author_role author
author2 Rane,Vipul
Yeole,Ravindra
Shinde,Devanand
author2_role author
author
author
dc.contributor.author.fl_str_mv Patil,Kiran
Rane,Vipul
Yeole,Ravindra
Shinde,Devanand
dc.subject.por.fl_str_mv repaglinide
enantiomeric purity
chiral LC
method validation
topic repaglinide
enantiomeric purity
chiral LC
method validation
description A simple, rapid, isocratic, normal phase chiral HPLC method was developed and validated for the enantiomeric separation of repaglinide, (S)-(+)-2-ethoxy-4-N [1-(2-piperidinophenyl)-3-methyl-1-butyl] aminocarbonylmethyl] benzoic acid, an antidiabetic drug substance. The enantiomers of repaglinide were resolved on a Chiralpak IA (immobilized amylose based stationary phase) column using a mobile phase consisting of n-hexane:ethanol:trifluoroacetic acid (80:20:0.2, v/v/v) at a flow rate of 1.0 mL min-1. The resolution between both enantiomers was greater than 2 in the optimized method. The developed method was extensively validated and proved to be robust, enantioselective, accurate, precise, and suitable for quantitative determination of (R)-enantiomer in bulk drug substance and product.
publishDate 2012
dc.date.none.fl_str_mv 2012-06-01
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=S0103-50532012000600008
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532012000600008
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S0103-50532012000600008
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 Journal of the Brazilian Chemical Society v.23 n.6 2012
reponame:Journal of the Brazilian Chemical Society (Online)
instname:Sociedade Brasileira de Química (SBQ)
instacron:SBQ
instname_str Sociedade Brasileira de Química (SBQ)
instacron_str SBQ
institution SBQ
reponame_str Journal of the Brazilian Chemical Society (Online)
collection Journal of the Brazilian Chemical Society (Online)
repository.name.fl_str_mv Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ)
repository.mail.fl_str_mv ||office@jbcs.sbq.org.br
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