Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations
Autor(a) principal: | |
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Data de Publicação: | 2009 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Química Nova (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422009000900021 |
Resumo: | A gas chromatographic method has been developed for the assay of fluvastatin sodium (FLU). FLU was silylated with N,O-bis(trimethylsilyl)trifluoroacetamide-1% trimethylchlorosilane at 90 ºC for 30 min and analysed in a DB-1 column by capillary gas chromatograph with a flame ionization detector. The method was validated. The assay was linear over the concentration range at 10.0 to 50.0 µg mL-1. The limit of detection and the limit of quantitation were 1.0 and 3.0 µg mL-1, respectively. The recoveries of FLU derivatives were in the range of 99.25-99.80%. In inter-day and intra-day analysis, the values of relative standard deviation (%) and the relative mean error (%) were found between 0.20-0.80% and -0.20-0.75%, respectively. The developed method was succesfully applied to analyze the FLU content in tablet formulation. The results were statistically compared with those obtained by the official method, and no significant difference was found between the two methods. Therefore, it can be recommended for the quality control assay of FLU in pharmaceutical industry. |
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Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparationsfluvastatinvalidationpharmaceutical preparationsA gas chromatographic method has been developed for the assay of fluvastatin sodium (FLU). FLU was silylated with N,O-bis(trimethylsilyl)trifluoroacetamide-1% trimethylchlorosilane at 90 ºC for 30 min and analysed in a DB-1 column by capillary gas chromatograph with a flame ionization detector. The method was validated. The assay was linear over the concentration range at 10.0 to 50.0 µg mL-1. The limit of detection and the limit of quantitation were 1.0 and 3.0 µg mL-1, respectively. The recoveries of FLU derivatives were in the range of 99.25-99.80%. In inter-day and intra-day analysis, the values of relative standard deviation (%) and the relative mean error (%) were found between 0.20-0.80% and -0.20-0.75%, respectively. The developed method was succesfully applied to analyze the FLU content in tablet formulation. The results were statistically compared with those obtained by the official method, and no significant difference was found between the two methods. Therefore, it can be recommended for the quality control assay of FLU in pharmaceutical industry.Sociedade Brasileira de Química2009-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422009000900021Química Nova v.32 n.9 2009reponame:Química Nova (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.1590/S0100-40422009000900021info:eu-repo/semantics/openAccessAslan,Serap SaglikErsoy,Olcay Sagirli and Laleeng2010-01-06T00:00:00Zoai:scielo:S0100-40422009000900021Revistahttps://www.scielo.br/j/qn/ONGhttps://old.scielo.br/oai/scielo-oai.phpquimicanova@sbq.org.br1678-70640100-4042opendoar:2010-01-06T00:00Química Nova (Online) - Sociedade Brasileira de Química (SBQ)false |
dc.title.none.fl_str_mv |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
title |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
spellingShingle |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations Aslan,Serap Saglik fluvastatin validation pharmaceutical preparations |
title_short |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
title_full |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
title_fullStr |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
title_full_unstemmed |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
title_sort |
Development and validation of a GC-FID assay for determination of fluvastatin in pharmaceutical preparations |
author |
Aslan,Serap Saglik |
author_facet |
Aslan,Serap Saglik Ersoy,Olcay Sagirli and Lale |
author_role |
author |
author2 |
Ersoy,Olcay Sagirli and Lale |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Aslan,Serap Saglik Ersoy,Olcay Sagirli and Lale |
dc.subject.por.fl_str_mv |
fluvastatin validation pharmaceutical preparations |
topic |
fluvastatin validation pharmaceutical preparations |
description |
A gas chromatographic method has been developed for the assay of fluvastatin sodium (FLU). FLU was silylated with N,O-bis(trimethylsilyl)trifluoroacetamide-1% trimethylchlorosilane at 90 ºC for 30 min and analysed in a DB-1 column by capillary gas chromatograph with a flame ionization detector. The method was validated. The assay was linear over the concentration range at 10.0 to 50.0 µg mL-1. The limit of detection and the limit of quantitation were 1.0 and 3.0 µg mL-1, respectively. The recoveries of FLU derivatives were in the range of 99.25-99.80%. In inter-day and intra-day analysis, the values of relative standard deviation (%) and the relative mean error (%) were found between 0.20-0.80% and -0.20-0.75%, respectively. The developed method was succesfully applied to analyze the FLU content in tablet formulation. The results were statistically compared with those obtained by the official method, and no significant difference was found between the two methods. Therefore, it can be recommended for the quality control assay of FLU in pharmaceutical industry. |
publishDate |
2009 |
dc.date.none.fl_str_mv |
2009-01-01 |
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=S0100-40422009000900021 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422009000900021 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S0100-40422009000900021 |
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.32 n.9 2009 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 |
_version_ |
1750318109918494720 |