Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection

Detalhes bibliográficos
Autor(a) principal: Vieira, Daniela C. M.
Data de Publicação: 2014
Outros Autores: Fiuza, Thalita F. M. [UNESP], Salgado, Hérida R. N. [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.3390/pathogens3030656
http://hdl.handle.net/11449/131019
Resumo: The cefuroxime sodium is a second generation cephalosporin indicated for infections caused by Gram-positive and Gram-negative microorganisms. Although this drug is highly studied and researched regarding the antimicrobial activity, pharmacokinetics and pharmacodynamics, there are few studies regarding the development of analytical methodology for this cephalosporin. Thus, research involving analytical methods is essential and highly relevant to optimize its analysis in the pharmaceutical industry and guarantee the quality of the product already sold. This study describes the development and validation of a microbiological assay applying the turbidimetric method for the determination of cefuroxime, using Micrococcus luteus ATCC 9341 as micro-organism test and 3x3 parallel line assay design, with nine tubes for each assay, as recommended by the Brazilian Pharmacopoeia. The developed and validated method showed excellent results of linearity, seletivity, precision and robustness, in the concentration range from 30.0 to 120.0 mg/mL, with 100.21% accuracy and content 99.97% to cefuroxime sodium in injectable pharmaceutical form.
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spelling Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injectionCefuroxime sodiumMicrobiological testingQuality controlValidation and stabilityThe cefuroxime sodium is a second generation cephalosporin indicated for infections caused by Gram-positive and Gram-negative microorganisms. Although this drug is highly studied and researched regarding the antimicrobial activity, pharmacokinetics and pharmacodynamics, there are few studies regarding the development of analytical methodology for this cephalosporin. Thus, research involving analytical methods is essential and highly relevant to optimize its analysis in the pharmaceutical industry and guarantee the quality of the product already sold. This study describes the development and validation of a microbiological assay applying the turbidimetric method for the determination of cefuroxime, using Micrococcus luteus ATCC 9341 as micro-organism test and 3x3 parallel line assay design, with nine tubes for each assay, as recommended by the Brazilian Pharmacopoeia. The developed and validated method showed excellent results of linearity, seletivity, precision and robustness, in the concentration range from 30.0 to 120.0 mg/mL, with 100.21% accuracy and content 99.97% to cefuroxime sodium in injectable pharmaceutical form.Fundação para o Desenvolvimento da UNESP (FUNDUNESP)Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Faculdade Pitágoras - Campus Poços de Caldas, Av. João Pinheiro, 1046, Poços de Caldas -MG 37701-014, Brazil. danicmvieira@yahoo.com.br.Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista Júlio de Mesquita Filho, Araraquara14800-901, SP, Brazil. thalitafiuza@uol.com.br.Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista Júlio de Mesquita Filho, Araraquara14800-901, SP, Brazil. salgadoh@fcfar.unesp.br.Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista Júlio de Mesquita Filho, Araraquara14800-901, SP, Brazil. thalitafiuza@uol.com.br.Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, Universidade Estadual Paulista Júlio de Mesquita Filho, Araraquara14800-901, SP, Brazil. salgadoh@fcfar.unesp.br.PathogensFaculdade Pitágoras - Campus Poços de Caldas, Av. João Pinheiro, 1046, Poços de Caldas -MG 37701-014, Brazil. danicmvieira@yahoo.com.br.Universidade Estadual Paulista (Unesp)Vieira, Daniela C. M.Fiuza, Thalita F. M. [UNESP]Salgado, Hérida R. N. [UNESP]2015-12-07T15:30:56Z2015-12-07T15:30:56Z2014info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article656-666application/pdfhttp://dx.doi.org/10.3390/pathogens3030656Pathogens (basel, Switzerland), v. 3, n. 3, p. 656-666, 2014.2076-0817http://hdl.handle.net/11449/13101910.3390/pathogens3030656PMC4243433.pdf25438016PMC4243433PubMedreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengPathogens (basel, Switzerland)1,421info:eu-repo/semantics/openAccess2024-06-24T13:46:00Zoai:repositorio.unesp.br:11449/131019Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T19:46:47.509170Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
title Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
spellingShingle Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
Vieira, Daniela C. M.
Cefuroxime sodium
Microbiological testing
Quality control
Validation and stability
title_short Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
title_full Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
title_fullStr Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
title_full_unstemmed Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
title_sort Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection
author Vieira, Daniela C. M.
author_facet Vieira, Daniela C. M.
Fiuza, Thalita F. M. [UNESP]
Salgado, Hérida R. N. [UNESP]
author_role author
author2 Fiuza, Thalita F. M. [UNESP]
Salgado, Hérida R. N. [UNESP]
author2_role author
author
dc.contributor.none.fl_str_mv Faculdade Pitágoras - Campus Poços de Caldas, Av. João Pinheiro, 1046, Poços de Caldas -MG 37701-014, Brazil. danicmvieira@yahoo.com.br.
Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Vieira, Daniela C. M.
Fiuza, Thalita F. M. [UNESP]
Salgado, Hérida R. N. [UNESP]
dc.subject.por.fl_str_mv Cefuroxime sodium
Microbiological testing
Quality control
Validation and stability
topic Cefuroxime sodium
Microbiological testing
Quality control
Validation and stability
description The cefuroxime sodium is a second generation cephalosporin indicated for infections caused by Gram-positive and Gram-negative microorganisms. Although this drug is highly studied and researched regarding the antimicrobial activity, pharmacokinetics and pharmacodynamics, there are few studies regarding the development of analytical methodology for this cephalosporin. Thus, research involving analytical methods is essential and highly relevant to optimize its analysis in the pharmaceutical industry and guarantee the quality of the product already sold. This study describes the development and validation of a microbiological assay applying the turbidimetric method for the determination of cefuroxime, using Micrococcus luteus ATCC 9341 as micro-organism test and 3x3 parallel line assay design, with nine tubes for each assay, as recommended by the Brazilian Pharmacopoeia. The developed and validated method showed excellent results of linearity, seletivity, precision and robustness, in the concentration range from 30.0 to 120.0 mg/mL, with 100.21% accuracy and content 99.97% to cefuroxime sodium in injectable pharmaceutical form.
publishDate 2014
dc.date.none.fl_str_mv 2014
2015-12-07T15:30:56Z
2015-12-07T15:30:56Z
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/10.3390/pathogens3030656
Pathogens (basel, Switzerland), v. 3, n. 3, p. 656-666, 2014.
2076-0817
http://hdl.handle.net/11449/131019
10.3390/pathogens3030656
PMC4243433.pdf
25438016
PMC4243433
url http://dx.doi.org/10.3390/pathogens3030656
http://hdl.handle.net/11449/131019
identifier_str_mv Pathogens (basel, Switzerland), v. 3, n. 3, p. 656-666, 2014.
2076-0817
10.3390/pathogens3030656
PMC4243433.pdf
25438016
PMC4243433
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Pathogens (basel, Switzerland)
1,421
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 656-666
application/pdf
dc.publisher.none.fl_str_mv Pathogens
publisher.none.fl_str_mv Pathogens
dc.source.none.fl_str_mv PubMed
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_ 1808129117431791616

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