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: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1590/s1984-82502016000300011 http://hdl.handle.net/11449/178472 |
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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Stability-indicating RP-LC method for quantification of fusidic acid in creamChromatography/reversed-phaseFusidic acid/stability-indicating/quality control/validationFusidic 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.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Department of Pharmaceuticals School of Pharmaceutical Sciences UNESP - Univ Estadual Paulista, Campus de AraraquaraDepartment of Pharmaceuticals School of Pharmaceutical Sciences UNESP - Univ Estadual Paulista, Campus de AraraquaraFAPESP: 2013/02861-3Universidade Estadual Paulista (Unesp)Curbete, Mariane Machado [UNESP]Salgado, Hérida Regina Nunes [UNESP]2018-12-11T17:30:30Z2018-12-11T17:30:30Z2016-07-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article447-457application/pdfhttp://dx.doi.org/10.1590/s1984-82502016000300011Brazilian Journal of Pharmaceutical Sciences, v. 52, n. 3, p. 447-457, 2016.2175-97901984-8250http://hdl.handle.net/11449/17847210.1590/s1984-82502016000300011S1984-825020160003004472-s2.0-85005987338S1984-82502016000300447.pdfScopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengBrazilian Journal of Pharmaceutical Sciences0,2140,214info:eu-repo/semantics/openAccess2024-06-24T13:46:32Zoai:repositorio.unesp.br:11449/178472Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-06-24T13:46:32Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)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 [UNESP] Chromatography/reversed-phase Fusidic acid/stability-indicating/quality control/validation |
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 [UNESP] |
author_facet |
Curbete, Mariane Machado [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
author_role |
author |
author2 |
Salgado, Hérida Regina Nunes [UNESP] |
author2_role |
author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (Unesp) |
dc.contributor.author.fl_str_mv |
Curbete, Mariane Machado [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
dc.subject.por.fl_str_mv |
Chromatography/reversed-phase Fusidic acid/stability-indicating/quality control/validation |
topic |
Chromatography/reversed-phase Fusidic acid/stability-indicating/quality control/validation |
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 |
2016-07-01 2018-12-11T17:30:30Z 2018-12-11T17:30:30Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1590/s1984-82502016000300011 Brazilian Journal of Pharmaceutical Sciences, v. 52, n. 3, p. 447-457, 2016. 2175-9790 1984-8250 http://hdl.handle.net/11449/178472 10.1590/s1984-82502016000300011 S1984-82502016000300447 2-s2.0-85005987338 S1984-82502016000300447.pdf |
url |
http://dx.doi.org/10.1590/s1984-82502016000300011 http://hdl.handle.net/11449/178472 |
identifier_str_mv |
Brazilian Journal of Pharmaceutical Sciences, v. 52, n. 3, p. 447-457, 2016. 2175-9790 1984-8250 10.1590/s1984-82502016000300011 S1984-82502016000300447 2-s2.0-85005987338 S1984-82502016000300447.pdf |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences 0,214 0,214 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
447-457 application/pdf |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1803045548777799680 |