Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.3390/pharmaceutics3030572 http://hdl.handle.net/11449/72643 |
Resumo: | Orbifloxacin is a fluoroquinolone with broad-spectrum antimicrobial activity, and belongs to the third generation of quinolones. Regarding the quality control of medicines, a validated microbiological assay for determination of orbifloxacin in pharmaceutical formulations has not as yet been reported. For this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify orbifloxacin in tablet formulations. The assay is based on the inhibitory effect of orbifloxacin upon the strain of Staphylococcus aureus ATCC 25923 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9992) in the selected range of 16.0-64.0 μg/mL, precise with relative standard deviation (RSD) of repeatability intraday = 2.88%, intermediate precision RSD = 3.33%, and accurate (100.31%). The results demonstrated the validity of the proposed bioassay, which allows reliable orbifloxacin quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2011 by the authors; licensee MDPI, Basel, Switzerland. |
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Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparationsBioassayFluoroquinolonesOrbifloxacinValidationorbifloxacinanalysis of varianceantibacterial activitybioassaydrug determinationmicrobiological agar assaynonhumanquality controlquantitative analysisStaphylococcus aureustablet formulationvalidation processvalidityOrbifloxacin is a fluoroquinolone with broad-spectrum antimicrobial activity, and belongs to the third generation of quinolones. Regarding the quality control of medicines, a validated microbiological assay for determination of orbifloxacin in pharmaceutical formulations has not as yet been reported. For this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify orbifloxacin in tablet formulations. The assay is based on the inhibitory effect of orbifloxacin upon the strain of Staphylococcus aureus ATCC 25923 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9992) in the selected range of 16.0-64.0 μg/mL, precise with relative standard deviation (RSD) of repeatability intraday = 2.88%, intermediate precision RSD = 3.33%, and accurate (100.31%). The results demonstrated the validity of the proposed bioassay, which allows reliable orbifloxacin quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2011 by the authors; licensee MDPI, Basel, Switzerland.Faculdade de Ciências Farmacêuticas Univ Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SPFaculdade de Ciências Farmacêuticas Univ Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SPUniversidade Estadual Paulista (Unesp)Cazedey, Edith C. L. [UNESP]Salgado, Hérida Regina Nunes [UNESP]2014-05-27T11:25:59Z2014-05-27T11:25:59Z2011-09-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article572-581application/pdfhttp://dx.doi.org/10.3390/pharmaceutics3030572Pharmaceutics, v. 3, n. 3, p. 572-581, 2011.1999-4923http://hdl.handle.net/11449/7264310.3390/pharmaceutics30305722-s2.0-800529754892-s2.0-80052975489.pdfScopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengPharmaceutics3.7460,949info:eu-repo/semantics/openAccess2024-06-24T13:46:23Zoai:repositorio.unesp.br:11449/72643Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T22:04:38.364663Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
title |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
spellingShingle |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations Cazedey, Edith C. L. [UNESP] Bioassay Fluoroquinolones Orbifloxacin Validation orbifloxacin analysis of variance antibacterial activity bioassay drug determination microbiological agar assay nonhuman quality control quantitative analysis Staphylococcus aureus tablet formulation validation process validity |
title_short |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
title_full |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
title_fullStr |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
title_full_unstemmed |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
title_sort |
Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations |
author |
Cazedey, Edith C. L. [UNESP] |
author_facet |
Cazedey, Edith C. L. [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 |
Cazedey, Edith C. L. [UNESP] Salgado, Hérida Regina Nunes [UNESP] |
dc.subject.por.fl_str_mv |
Bioassay Fluoroquinolones Orbifloxacin Validation orbifloxacin analysis of variance antibacterial activity bioassay drug determination microbiological agar assay nonhuman quality control quantitative analysis Staphylococcus aureus tablet formulation validation process validity |
topic |
Bioassay Fluoroquinolones Orbifloxacin Validation orbifloxacin analysis of variance antibacterial activity bioassay drug determination microbiological agar assay nonhuman quality control quantitative analysis Staphylococcus aureus tablet formulation validation process validity |
description |
Orbifloxacin is a fluoroquinolone with broad-spectrum antimicrobial activity, and belongs to the third generation of quinolones. Regarding the quality control of medicines, a validated microbiological assay for determination of orbifloxacin in pharmaceutical formulations has not as yet been reported. For this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify orbifloxacin in tablet formulations. The assay is based on the inhibitory effect of orbifloxacin upon the strain of Staphylococcus aureus ATCC 25923 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9992) in the selected range of 16.0-64.0 μg/mL, precise with relative standard deviation (RSD) of repeatability intraday = 2.88%, intermediate precision RSD = 3.33%, and accurate (100.31%). The results demonstrated the validity of the proposed bioassay, which allows reliable orbifloxacin quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2011 by the authors; licensee MDPI, Basel, Switzerland. |
publishDate |
2011 |
dc.date.none.fl_str_mv |
2011-09-01 2014-05-27T11:25:59Z 2014-05-27T11:25:59Z |
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/pharmaceutics3030572 Pharmaceutics, v. 3, n. 3, p. 572-581, 2011. 1999-4923 http://hdl.handle.net/11449/72643 10.3390/pharmaceutics3030572 2-s2.0-80052975489 2-s2.0-80052975489.pdf |
url |
http://dx.doi.org/10.3390/pharmaceutics3030572 http://hdl.handle.net/11449/72643 |
identifier_str_mv |
Pharmaceutics, v. 3, n. 3, p. 572-581, 2011. 1999-4923 10.3390/pharmaceutics3030572 2-s2.0-80052975489 2-s2.0-80052975489.pdf |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Pharmaceutics 3.746 0,949 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
572-581 application/pdf |
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_ |
1808129389520486400 |