Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection
Autor(a) principal: | |
---|---|
Data de Publicação: | 2013 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1590/S1984-82502015000300014 http://hdl.handle.net/11449/133748 |
Resumo: | Norfloxacin is one of the first commercially available (and most widely used) fluoroquinolone antibiotics. This paper reports the development and validation of a simple, sensitive, accurate and reproducible turbidimetric assay method to quantify norfloxacin in tablets formulations in only 4 hours. The bioassay is based on the inhibitory effect of norfloxacin upon the strain ofStaphylococcus epidermidis ATCC 12228 IAL 2150 used as test microorganism. The assay was performed 3x3 parallel lines like, three tubes for each concentration of reference substance and three tubes for each sample concentration. The results were treated statistically by analysis of variance and were found to be linear (r2 = 0.9999) in the selected range of 25-100 μg mL-1; precise (intra-assay: relative standard deviation (RSD) = 1.33%; inter-assay: RSD = 0.21%), accurate (100.74%) and robust with RSD lower than 4.5%. The student's t-test showed no statistically significant difference between the proposed turbidimetric method and an HPLC method previously validated. However the turbidimetric assay can be used as a valuable alternative methodology for the routine quality control of this medicine, complementary to other physical-chemical methods. |
id |
UNSP_4384187a3490b49de048fce4904782b8 |
---|---|
oai_identifier_str |
oai:repositorio.unesp.br:11449/133748 |
network_acronym_str |
UNSP |
network_name_str |
Repositório Institucional da UNESP |
repository_id_str |
2946 |
spelling |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injectionMicrobiological assayQuality controlNorfloxacin/quantification in tabletsTurbidimetric method/quality control/validationAntimicrobials/quality controlEnsaio microbiológicoNorfloxacino/quantificação em comprimidosMétodo turbidimétrico/controle de qualidade/validaçãoAntimicrobianos/controle de qualidadeNorfloxacin is one of the first commercially available (and most widely used) fluoroquinolone antibiotics. This paper reports the development and validation of a simple, sensitive, accurate and reproducible turbidimetric assay method to quantify norfloxacin in tablets formulations in only 4 hours. The bioassay is based on the inhibitory effect of norfloxacin upon the strain ofStaphylococcus epidermidis ATCC 12228 IAL 2150 used as test microorganism. The assay was performed 3x3 parallel lines like, three tubes for each concentration of reference substance and three tubes for each sample concentration. The results were treated statistically by analysis of variance and were found to be linear (r2 = 0.9999) in the selected range of 25-100 μg mL-1; precise (intra-assay: relative standard deviation (RSD) = 1.33%; inter-assay: RSD = 0.21%), accurate (100.74%) and robust with RSD lower than 4.5%. The student's t-test showed no statistically significant difference between the proposed turbidimetric method and an HPLC method previously validated. However the turbidimetric assay can be used as a valuable alternative methodology for the routine quality control of this medicine, complementary to other physical-chemical methods.O norfloxacino foi a primeira fluorquinolona (e mais utilizada) disponível no mercado. Este trabalho divulga um novo desenvolvimento e validação de um método turbidimétrico simples, sensível, preciso e reprodutível para a quantificação de norfloxacino em comprimidos em apenas 4 horas. O bioensaio é baseado no efeito inibitório de norfloxacino sobre a cepa Staphylococcus epidermidis ATCC 12228 IAL 2150, utilizada como micro-organismo teste. O bioensaio foi efetuado através do delineamento de linhas paralelas 3x3, em que três tubos foram utilizados para a solução padrão e três tubos para as concentrações da amostra. Os resultados foram tratados estatisticamente pela análise de variância, apresentando coeficiente de correlação linear der2 = 0,9999, na faixa de 20 a 100 μg mL-1; precisão (intra-ensaio: desvio padrão relativo (RSD) 1,33%; inter-ensaio: RSD=0,21%), exatidão (100,74%) e robustez com RSD menor que 4,5%. O teste-tmostrou não haver diferença estatisticamente significativa entre o método turbidimétrico proposto e um método por HPLC previamente validado. No entanto, o ensaio turbidimétrico pode ser utilizado como método alternativo para o controle de qualidade de rotina para este antimicrobiano, como um complemento de outros métodos físico-químicos.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)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, BrasilFAPESP: 2010/13335-2Universidade Estadual Paulista (Unesp)Tótoli, Eliane Gandolpho [UNESP]Salgado, Hérida Regina Nunes [UNESP]2016-01-28T16:56:27Z2016-01-28T16:56:27Z2013info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article5923-5928application/pdfhttp://dx.doi.org/10.1590/S1984-82502015000300014Analytical Methods, v. 5, n. 21, p. 629-635-5928, 2013.1759-9660http://hdl.handle.net/11449/13374810.1590/S1984-82502015000300014S1984-82502015000300629S1984-82502015000300629.pdf46635156597588889881720291571774Currículo Lattesreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengAnalytical Methods2.0730,619info:eu-repo/semantics/openAccess2024-06-24T13:46:33Zoai:repositorio.unesp.br:11449/133748Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T23:26:23.209896Repositório 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 ampicillin sodium in powder for solution for injection |
title |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection |
spellingShingle |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection Tótoli, Eliane Gandolpho [UNESP] Microbiological assay Quality control Norfloxacin/quantification in tablets Turbidimetric method/quality control/validation Antimicrobials/quality control Ensaio microbiológico Norfloxacino/quantificação em comprimidos Método turbidimétrico/controle de qualidade/validação Antimicrobianos/controle de qualidade |
title_short |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection |
title_full |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection |
title_fullStr |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection |
title_full_unstemmed |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection |
title_sort |
Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection |
author |
Tótoli, Eliane Gandolpho [UNESP] |
author_facet |
Tótoli, Eliane Gandolpho [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 |
Tótoli, Eliane Gandolpho [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
dc.subject.por.fl_str_mv |
Microbiological assay Quality control Norfloxacin/quantification in tablets Turbidimetric method/quality control/validation Antimicrobials/quality control Ensaio microbiológico Norfloxacino/quantificação em comprimidos Método turbidimétrico/controle de qualidade/validação Antimicrobianos/controle de qualidade |
topic |
Microbiological assay Quality control Norfloxacin/quantification in tablets Turbidimetric method/quality control/validation Antimicrobials/quality control Ensaio microbiológico Norfloxacino/quantificação em comprimidos Método turbidimétrico/controle de qualidade/validação Antimicrobianos/controle de qualidade |
description |
Norfloxacin is one of the first commercially available (and most widely used) fluoroquinolone antibiotics. This paper reports the development and validation of a simple, sensitive, accurate and reproducible turbidimetric assay method to quantify norfloxacin in tablets formulations in only 4 hours. The bioassay is based on the inhibitory effect of norfloxacin upon the strain ofStaphylococcus epidermidis ATCC 12228 IAL 2150 used as test microorganism. The assay was performed 3x3 parallel lines like, three tubes for each concentration of reference substance and three tubes for each sample concentration. The results were treated statistically by analysis of variance and were found to be linear (r2 = 0.9999) in the selected range of 25-100 μg mL-1; precise (intra-assay: relative standard deviation (RSD) = 1.33%; inter-assay: RSD = 0.21%), accurate (100.74%) and robust with RSD lower than 4.5%. The student's t-test showed no statistically significant difference between the proposed turbidimetric method and an HPLC method previously validated. However the turbidimetric assay can be used as a valuable alternative methodology for the routine quality control of this medicine, complementary to other physical-chemical methods. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013 2016-01-28T16:56:27Z 2016-01-28T16:56:27Z |
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/S1984-82502015000300014 Analytical Methods, v. 5, n. 21, p. 629-635-5928, 2013. 1759-9660 http://hdl.handle.net/11449/133748 10.1590/S1984-82502015000300014 S1984-82502015000300629 S1984-82502015000300629.pdf 4663515659758888 9881720291571774 |
url |
http://dx.doi.org/10.1590/S1984-82502015000300014 http://hdl.handle.net/11449/133748 |
identifier_str_mv |
Analytical Methods, v. 5, n. 21, p. 629-635-5928, 2013. 1759-9660 10.1590/S1984-82502015000300014 S1984-82502015000300629 S1984-82502015000300629.pdf 4663515659758888 9881720291571774 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Analytical Methods 2.073 0,619 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
5923-5928 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_ |
1808128239937257472 |