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A Validated Stability-Indicating LC Method for Orbifloxacin in the Presence of Degradation Products

dc.contributor.authorCazedey, Edith C. L. [UNESP]
dc.contributor.authorOthman, Asma
dc.contributor.authorGarg, Sanjay
dc.contributor.authorSalgado, Hérida Regina Nunes [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionUniv Auckland
dc.date.accessioned2014-05-20T15:31:41Z
dc.date.available2014-05-20T15:31:41Z
dc.date.issued2011-08-01
dc.description.abstractA stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of orbifloxacin in tablet dosage forms. Reversed-phase chromatography was performed on a Symmetry Shield RP-18 Waters (R), 250mmx4.6mm i.d., 5 mu m particle size column with 5% acetic acid: methanol (80:20, v/v) as mobile phase at a flow rate of 0.7 ml/min. PDA detection was performed at 290 nm. A well resolved peak was obtained for orbifloxacin at a retention time of approximately 7.9 min. For stress studies the drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. The developed method was validated as per ICH guidelines for the parameters such as system suitability, linearity, limit of quantification (LOQ), limit of detection (LOD), precision, accuracy, selectivity and robustness. Results obtained were found to be satisfactory. No interference from any excipients in the pharmaceutical dosage form or degradation products was observed.en
dc.description.affiliationSão Paulo State Univ, Fac Pharmaceut Sci, Sch Pharm, São Paulo, Brazil
dc.description.affiliationUniv Auckland, Fac Med & Hlth Sci, Sch Pharm, Auckland 1, New Zealand
dc.description.affiliationUnespSão Paulo State Univ, Fac Pharmaceut Sci, Sch Pharm, São Paulo, Brazil
dc.description.sponsorshipPACD-FCFAr-UNESP (Araraquara, Brazil)
dc.description.sponsorshipFundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
dc.description.sponsorshipConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
dc.format.extent176-181
dc.identifierhttp://dx.doi.org/10.2174/157341211796353264
dc.identifier.citationCurrent Pharmaceutical Analysis. Sharjah: Bentham Science Publ Ltd, v. 7, n. 3, p. 176-181, 2011.
dc.identifier.doi10.2174/157341211796353264
dc.identifier.issn1573-4129
dc.identifier.urihttp://hdl.handle.net/11449/40754
dc.identifier.wosWOS:000294418800004
dc.language.isoeng
dc.publisherBentham Science Publ Ltd
dc.relation.ispartofCurrent Pharmaceutical Analysis
dc.relation.ispartofjcr0.859
dc.relation.ispartofsjr0,224
dc.rights.accessRightsAcesso restritopt
dc.sourceWeb of Science
dc.subjectDegradation productsen
dc.subjectHPLC-UVen
dc.subjectLiquid chromatographyen
dc.subjectOrbifloxacinen
dc.subjectStability-indicating methoden
dc.subjectValidationen
dc.titleA Validated Stability-Indicating LC Method for Orbifloxacin in the Presence of Degradation Productsen
dc.typeResenhapt
dcterms.licensehttp://www.benthamscience.com/permission.php
dcterms.rightsHolderBentham Science Publ Ltd
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.author.orcid0000-0001-7253-2629[3]
unesp.author.orcid0000-0002-0385-340X[4]
unesp.campusUniversidade Estadual Paulista (UNESP), Faculdade de Ciências Farmacêuticas, Araraquarapt
unesp.departmentFármacos e Medicamentos - FCFpt

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