Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

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dc.contributor.authorPedroso, Tahisa Marcela [UNESP]
dc.contributor.authorSalgado, Hérida Regina Nunes [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.date.accessioned2014-12-03T13:11:43Z
dc.date.available2014-12-03T13:11:43Z
dc.date.issued2014-01-01
dc.description.abstractA 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 C-18 column (250 Chi 4.6 mm, 5 mu m), 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 (r(2)= 0.9999) over the concentration range of 30-80 mu g 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.en
dc.description.affiliationUniv State Sao Paulo Julio de Mesquita Filho, Sch Pharmaceut Sci, Dept Drugs & Pharmaceut, Araraquara, SP, Brazil
dc.description.affiliationUnespUniv State Sao Paulo Julio de Mesquita Filho, Sch Pharmaceut Sci, Dept Drugs & Pharmaceut, Araraquara, SP, Brazil
dc.description.sponsorshipFundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
dc.description.sponsorshipConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
dc.description.sponsorshipPADC - UNESP
dc.format.extent213-223
dc.identifierhttp://dx.doi.org/10.1590/S1984-82502011000100022
dc.identifier.citationBrazilian Journal Of Pharmaceutical Sciences. Sao Paulo: Univ Sao Paulo, Conjunto Quimicas, v. 50, n. 1, p. 213-223, 2014.
dc.identifier.doi10.1590/S1984-82502011000100022
dc.identifier.fileS1984-82502014000100022.pdf
dc.identifier.issn1984-8250
dc.identifier.scieloS1984-82502011000100022
dc.identifier.urihttp://hdl.handle.net/11449/113462
dc.identifier.wosWOS:000336147100022
dc.language.isoeng
dc.publisherUniversidade de São Paulo (USP), Conjunto Quimicas
dc.relation.ispartofBrazilian Journal of Pharmaceutical Sciences
dc.relation.ispartofjcr0.483
dc.relation.ispartofsjr0,214
dc.rights.accessRightsAcesso aberto
dc.sourceWeb of Science
dc.subjectCefazolin sodium/determinationen
dc.subjectHigh performance liquid chromatography/reverse-phase/quantitative analysis Pharmaceutical industry/quality controlen
dc.subjectCefalosporine/quality controlen
dc.subjectMedicines/quality controlen
dc.titleValidation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industryen
dc.typeArtigo
dcterms.rightsHolderUniv Sao Paulo, Conjunto Quimicas
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Ciências Farmacêuticas, Araraquarapt

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