A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase
Autor(a) principal: | |
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Data de Publicação: | 2012 |
Outros Autores: | , , |
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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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 |
_version_ |
1750318173502046208 |