Stability-indicating RP-LC method for quantification of fusidic acid in cream
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Pharmaceutical Sciences |
Texto Completo: | https://www.revistas.usp.br/bjps/article/view/128342 |
Resumo: | Fusidic acid is an antibiotic steroid indicated for the treatment of infections caused by the genus Staphylococcus, including methicillin resistant Staphylococcus aureus strains, and other Gram-positive bacteria. In the present study, a stability-indicating reversed-phase liquid chromatography (RP-LC) method was developed and validated for the determination of fusidic acid in dermatological cream as an alternative to existing methods. Analyses were performed using a C18 column and guard column at room temperature, eluting with an isocratic mobile phase of acetonitrile and water (72:28, v/v), adjusted to pH 3.5 with acetic acid, pumped at a flow rate of 1.0 mL min-1, detection at 210 nm and 20 µL of injection volume. The forced degradation study was conducted under acidic, alkaline, neutral, photolytic, and oxidative stress conditions. The method was validated according to ICH and FDA guidelines; it was linear, precise, accurate, selective, and robust over concentrations of 5-95 µg mL-1, with detection and quantification limits of 0.43 and 1.31 μg mL-1, respectively. Therefore, we conclude that this method is suitable for quantifying fusidic acid in pharmaceutical dermatological creams and determining its stability, representing a more economical and practical alternative for routine analysis in quality control. |
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Brazilian Journal of Pharmaceutical Sciences |
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Stability-indicating RP-LC method for quantification of fusidic acid in cream Fusidic acid is an antibiotic steroid indicated for the treatment of infections caused by the genus Staphylococcus, including methicillin resistant Staphylococcus aureus strains, and other Gram-positive bacteria. In the present study, a stability-indicating reversed-phase liquid chromatography (RP-LC) method was developed and validated for the determination of fusidic acid in dermatological cream as an alternative to existing methods. Analyses were performed using a C18 column and guard column at room temperature, eluting with an isocratic mobile phase of acetonitrile and water (72:28, v/v), adjusted to pH 3.5 with acetic acid, pumped at a flow rate of 1.0 mL min-1, detection at 210 nm and 20 µL of injection volume. The forced degradation study was conducted under acidic, alkaline, neutral, photolytic, and oxidative stress conditions. The method was validated according to ICH and FDA guidelines; it was linear, precise, accurate, selective, and robust over concentrations of 5-95 µg mL-1, with detection and quantification limits of 0.43 and 1.31 μg mL-1, respectively. Therefore, we conclude that this method is suitable for quantifying fusidic acid in pharmaceutical dermatological creams and determining its stability, representing a more economical and practical alternative for routine analysis in quality control. Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2016-09-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/12834210.1590/s1984-82502016000300011Brazilian Journal of Pharmaceutical Sciences; Vol. 52 Núm. 3 (2016); 447-457Brazilian Journal of Pharmaceutical Sciences; v. 52 n. 3 (2016); 447-457Brazilian Journal of Pharmaceutical Sciences; Vol. 52 No. 3 (2016); 447-4572175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/128342/125215Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso)info:eu-repo/semantics/openAccessCurbete, Mariane MachadoSalgado, Hérida Regina Nunes2017-03-16T17:54:50Zoai:revistas.usp.br:article/128342Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2017-03-16T17:54:50Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
title |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
spellingShingle |
Stability-indicating RP-LC method for quantification of fusidic acid in cream Curbete, Mariane Machado |
title_short |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
title_full |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
title_fullStr |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
title_full_unstemmed |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
title_sort |
Stability-indicating RP-LC method for quantification of fusidic acid in cream |
author |
Curbete, Mariane Machado |
author_facet |
Curbete, Mariane Machado Salgado, Hérida Regina Nunes |
author_role |
author |
author2 |
Salgado, Hérida Regina Nunes |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Curbete, Mariane Machado Salgado, Hérida Regina Nunes |
description |
Fusidic acid is an antibiotic steroid indicated for the treatment of infections caused by the genus Staphylococcus, including methicillin resistant Staphylococcus aureus strains, and other Gram-positive bacteria. In the present study, a stability-indicating reversed-phase liquid chromatography (RP-LC) method was developed and validated for the determination of fusidic acid in dermatological cream as an alternative to existing methods. Analyses were performed using a C18 column and guard column at room temperature, eluting with an isocratic mobile phase of acetonitrile and water (72:28, v/v), adjusted to pH 3.5 with acetic acid, pumped at a flow rate of 1.0 mL min-1, detection at 210 nm and 20 µL of injection volume. The forced degradation study was conducted under acidic, alkaline, neutral, photolytic, and oxidative stress conditions. The method was validated according to ICH and FDA guidelines; it was linear, precise, accurate, selective, and robust over concentrations of 5-95 µg mL-1, with detection and quantification limits of 0.43 and 1.31 μg mL-1, respectively. Therefore, we conclude that this method is suitable for quantifying fusidic acid in pharmaceutical dermatological creams and determining its stability, representing a more economical and practical alternative for routine analysis in quality control. |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-09-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/128342 10.1590/s1984-82502016000300011 |
url |
https://www.revistas.usp.br/bjps/article/view/128342 |
identifier_str_mv |
10.1590/s1984-82502016000300011 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/128342/125215 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso) info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso) |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
dc.source.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences; Vol. 52 Núm. 3 (2016); 447-457 Brazilian Journal of Pharmaceutical Sciences; v. 52 n. 3 (2016); 447-457 Brazilian Journal of Pharmaceutical Sciences; Vol. 52 No. 3 (2016); 447-457 2175-9790 1984-8250 reponame:Brazilian Journal of Pharmaceutical Sciences instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Brazilian Journal of Pharmaceutical Sciences |
collection |
Brazilian Journal of Pharmaceutical Sciences |
repository.name.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
bjps@usp.br||elizabeth.igne@gmail.com |
_version_ |
1800222912832077824 |