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Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations

dc.contributor.authorCazedey, Edith C. L. [UNESP]
dc.contributor.authorSalgado, Hérida Regina Nunes [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.date.accessioned2014-05-27T11:25:59Z
dc.date.available2014-05-27T11:25:59Z
dc.date.issued2011-09-01
dc.description.abstractOrbifloxacin 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.en
dc.description.affiliationFaculdade de Ciências Farmacêuticas Univ Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP
dc.description.affiliationUnespFaculdade de Ciências Farmacêuticas Univ Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP
dc.format.extent572-581
dc.identifierhttp://dx.doi.org/10.3390/pharmaceutics3030572
dc.identifier.citationPharmaceutics, v. 3, n. 3, p. 572-581, 2011.
dc.identifier.doi10.3390/pharmaceutics3030572
dc.identifier.file2-s2.0-80052975489.pdf
dc.identifier.issn1999-4923
dc.identifier.scopus2-s2.0-80052975489
dc.identifier.urihttp://hdl.handle.net/11449/72643
dc.language.isoeng
dc.relation.ispartofPharmaceutics
dc.relation.ispartofjcr3.746
dc.relation.ispartofsjr0,949
dc.rights.accessRightsAcesso abertopt
dc.sourceScopus
dc.subjectBioassay
dc.subjectFluoroquinolones
dc.subjectOrbifloxacin
dc.subjectValidation
dc.subjectorbifloxacin
dc.subjectanalysis of variance
dc.subjectantibacterial activity
dc.subjectbioassay
dc.subjectdrug determination
dc.subjectmicrobiological agar assay
dc.subjectnonhuman
dc.subjectquality control
dc.subjectquantitative analysis
dc.subjectStaphylococcus aureus
dc.subjecttablet formulation
dc.subjectvalidation process
dc.subjectvalidity
dc.titleDevelopment and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparationsen
dc.typeArtigopt
dcterms.licensehttp://www.mdpi.com/about/openaccess
dspace.entity.typePublication
relation.isDepartmentOfPublicatione214da1b-9929-4ae9-b8fd-655e9bfeda4b
relation.isDepartmentOfPublication.latestForDiscoverye214da1b-9929-4ae9-b8fd-655e9bfeda4b
relation.isOrgUnitOfPublication95697b0b-8977-4af6-88d5-c29c80b5ee92
relation.isOrgUnitOfPublication.latestForDiscovery95697b0b-8977-4af6-88d5-c29c80b5ee92
unesp.campusUniversidade Estadual Paulista (UNESP), Faculdade de Ciências Farmacêuticas, Araraquarapt
unesp.departmentFármacos e Medicamentos - FCFpt

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