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
Autor(a) principal: | |
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Data de Publicação: | 2014 |
Outros Autores: | |
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/11449/227739 |
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 × 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 quantization. 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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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 industryCefalosporine/quality controlCefazolin sodium/determinationHigh performance liquid chromatography/reverse-phase/ quantitative analysisMedicines/ quality controlPharmaceutical industry/quality controlA 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 × 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 quantization. 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.Department of Drugs and Pharmaceuticals, School of Pharmaceutical Sciences, University of the State of São Paulo 'Júlio de Mesquita Filho', Araraquara, SPDepartment of Drugs and Pharmaceuticals, School of Pharmaceutical Sciences, University of the State of São Paulo 'Júlio de Mesquita Filho', Araraquara, SPUniversidade Estadual Paulista (UNESP)Pedroso, Tahisa Marcela [UNESP]Salgado, Hérida Regina Nunes [UNESP]2022-04-29T07:14:53Z2022-04-29T07:14:53Z2014-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article213-223http://dx.doi.org/10.1590/s1984-82502011000100022Brazilian Journal of Pharmaceutical Sciences, v. 50, n. 1, p. 213-223, 2014.2175-97901984-8250http://hdl.handle.net/11449/22773910.1590/s1984-825020110001000222-s2.0-84900444028Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengBrazilian Journal of Pharmaceutical Sciencesinfo:eu-repo/semantics/openAccess2024-06-24T13:45:07Zoai:repositorio.unesp.br:11449/227739Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T14:48:10.372594Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
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 |
title |
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 |
spellingShingle |
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 Pedroso, Tahisa Marcela [UNESP] Cefalosporine/quality control Cefazolin sodium/determination High performance liquid chromatography/reverse-phase/ quantitative analysis Medicines/ quality control Pharmaceutical industry/quality control |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
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 |
Cefalosporine/quality control Cefazolin sodium/determination High performance liquid chromatography/reverse-phase/ quantitative analysis Medicines/ quality control Pharmaceutical industry/quality control |
topic |
Cefalosporine/quality control Cefazolin sodium/determination High performance liquid chromatography/reverse-phase/ quantitative analysis Medicines/ quality control Pharmaceutical industry/quality control |
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 × 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 quantization. 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 |
2014-01-01 2022-04-29T07:14:53Z 2022-04-29T07:14:53Z |
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. 2175-9790 1984-8250 http://hdl.handle.net/11449/227739 10.1590/s1984-82502011000100022 2-s2.0-84900444028 |
url |
http://dx.doi.org/10.1590/s1984-82502011000100022 http://hdl.handle.net/11449/227739 |
identifier_str_mv |
Brazilian Journal of Pharmaceutical Sciences, v. 50, n. 1, p. 213-223, 2014. 2175-9790 1984-8250 10.1590/s1984-82502011000100022 2-s2.0-84900444028 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
213-223 |
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_ |
1808128420377264128 |