Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography

Detalhes bibliográficos
Autor(a) principal: Pedroso, Tahisa Marcela [UNESP]
Data de Publicação: 2014
Outros Autores: Salgado, Hérida Regina Nunes [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1590/S1984-82502011000100022
http://hdl.handle.net/11449/133749
Resumo: A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2 =0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy
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spelling Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatographyCefazolin sodium/determinationHigh performance liquid chromatography/reverse-phase/ quantitative analysisPharmaceutical industry/quality controlCefalosporine/quality controlMedicines/ quality controlCefazolina sódica/determinaçãoCromatografia líquida de alta eficiência/fase reversa/ análise quantitativaIndústria farmacêutica/controle de qualidadeCefalosporina/controle de qualidadeMedicamentos/controle de qualidadeA reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2 =0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacyUm método cromatográfico em fase reversa foi validado para a determinação de cefazolina sódica em pó liofilizado, a ser aplicado no controle de qualidade em indústrias farmacêuticas. O método por cromatografia líquida foi conduzido em coluna Zorbax Eclipse Plus C18 (250 × 4,6 mm, 5 µm) mantida à temperatura ambiente. A fase móvel consistiu de água purificada: acetonitrila (60 : 40 v/v), com o pH ajustado para 8 com trietilamina. A vazão usada foi de 0,5 mL min-1 e os analitos de interesse foram monitorizados a 270 nm. O tempo de retenção da cefazolina sódica foi de 3,6 min. As áreas dos picos de cefazolina sódica foram lineares na faixa de concentração de 30-80 µg mL-1 (r2 = 0,9999). A seletividade do método foi demonstrada através de estudos de degradação. O método demonstrou resultados satisfatórios para precisão, exatidão, limites de detecção e de quantificação. A robustez do método foi avaliada utilizando o esquema fatorial de Plackett-Burman com uma matriz de 15 experimentos simultâneos, e analisados por tratamento estatístico proposto por Youden e Steiner. Finalmente, o método proposto pode ser também uma opção de êxito para a análise de cefazolina sódica, contribuindo para o controle de qualidade e para garantir a eficácia terapêutica.Universidade Estadual Paulista Júlio de Mesquita Filho, Departamento de Farmacos e Médicamentos, Faculdade de Ciências Farmacêuticas de Araraquara, Araraquara, Rodovia Araraquara-Jaú, km1, Campus, CEP 14801-902, SP, BrasilUniversidade Estadual Paulista Júlio de Mesquita Filho, Departamento de Farmacos e Médicamentos, Faculdade de Ciências Farmacêuticas de Araraquara, Araraquara, Rodovia Araraquara-Jaú, km1, Campus, CEP 14801-902, SP, BrasilUniversidade Estadual Paulista (Unesp)Pedroso, Tahisa Marcela [UNESP]Salgado, Hérida Regina Nunes [UNESP]2016-01-28T16:56:28Z2016-01-28T16:56:28Z2014info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article213-223application/pdfhttp://dx.doi.org/10.1590/S1984-82502011000100022Brazilian Journal of Pharmaceutical Sciences, v. 50, n. 1, p. 213-223, 2014.1984-8250http://hdl.handle.net/11449/13374910.1590/S1984-82502011000100022S1984-82502014000100022ISSN1984-8250-2014-50-01-213-223.pdf42389722873554279881720291571774Currículo Lattesreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengBrazilian Journal of Pharmaceutical Sciences0.4830,214info:eu-repo/semantics/openAccess2024-06-24T13:45:39Zoai:repositorio.unesp.br:11449/133749Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-06-24T13:45:39Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
title Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
spellingShingle Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
Pedroso, Tahisa Marcela [UNESP]
Cefazolin sodium/determination
High performance liquid chromatography/reverse-phase/ quantitative analysis
Pharmaceutical industry/quality control
Cefalosporine/quality control
Medicines/ quality control
Cefazolina sódica/determinação
Cromatografia líquida de alta eficiência/fase reversa/ análise quantitativa
Indústria farmacêutica/controle de qualidade
Cefalosporina/controle de qualidade
Medicamentos/controle de qualidade
title_short Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
title_full Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
title_fullStr Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
title_full_unstemmed Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
title_sort Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
author Pedroso, Tahisa Marcela [UNESP]
author_facet Pedroso, Tahisa Marcela [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 Pedroso, Tahisa Marcela [UNESP]
Salgado, Hérida Regina Nunes [UNESP]
dc.subject.por.fl_str_mv Cefazolin sodium/determination
High performance liquid chromatography/reverse-phase/ quantitative analysis
Pharmaceutical industry/quality control
Cefalosporine/quality control
Medicines/ quality control
Cefazolina sódica/determinação
Cromatografia líquida de alta eficiência/fase reversa/ análise quantitativa
Indústria farmacêutica/controle de qualidade
Cefalosporina/controle de qualidade
Medicamentos/controle de qualidade
topic Cefazolin sodium/determination
High performance liquid chromatography/reverse-phase/ quantitative analysis
Pharmaceutical industry/quality control
Cefalosporine/quality control
Medicines/ quality control
Cefazolina sódica/determinação
Cromatografia líquida de alta eficiência/fase reversa/ análise quantitativa
Indústria farmacêutica/controle de qualidade
Cefalosporina/controle de qualidade
Medicamentos/controle de qualidade
description A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2 =0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy
publishDate 2014
dc.date.none.fl_str_mv 2014
2016-01-28T16:56:28Z
2016-01-28T16:56:28Z
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/S1984-82502011000100022
Brazilian Journal of Pharmaceutical Sciences, v. 50, n. 1, p. 213-223, 2014.
1984-8250
http://hdl.handle.net/11449/133749
10.1590/S1984-82502011000100022
S1984-82502014000100022
ISSN1984-8250-2014-50-01-213-223.pdf
4238972287355427
9881720291571774
url http://dx.doi.org/10.1590/S1984-82502011000100022
http://hdl.handle.net/11449/133749
identifier_str_mv Brazilian Journal of Pharmaceutical Sciences, v. 50, n. 1, p. 213-223, 2014.
1984-8250
10.1590/S1984-82502011000100022
S1984-82502014000100022
ISSN1984-8250-2014-50-01-213-223.pdf
4238972287355427
9881720291571774
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Brazilian Journal of Pharmaceutical Sciences
0.483
0,214
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 213-223
application/pdf
dc.source.none.fl_str_mv Currículo Lattes
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_ 1803649755957428224

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