Validation of a stability-indicating RP-LC method for the determination of tigecycline in lyophilized powder

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dc.contributor.authorDa Silva, Lucélia Magalhães [UNESP]
dc.contributor.authorSalgado, Hérida Regina Nunes [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.date.accessioned2014-05-27T11:28:18Z
dc.date.available2014-05-27T11:28:18Z
dc.date.issued2013-02-01
dc.description.abstractA reversed-phase liquid chromatography (RP-LC) method was validated for the determination of tigecycline in lyophilized powder. The LC method was conducted on a Luna C18 column (250 × 4.6 mm i.d.), maintained at room temperature. The mobile phase consisted of buffer containing sodium phosphate monobasic (0.015M) and oxalic acid (0.015M) (pH 7.0)-acetonitrile (75:25, v/v), run at a flow rate of 1.0 mL/min and using ultraviolet detection at 280 nm. The chromatographic separation was obtained with a retention time of 8.6 min, and was linear in the range of 40-100 μg/mL (r2 = 0.9997). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed no interference of the excipients. The accuracy was 99.01% with a bias lower than 1.81%. The limits of detection and quantitation were 1.67 and 5.05 μg/mL, respectively. Moreover, method validation demonstrated satisfactory results for precision and robustness. The proposed method was applied for the analysis of the lyophilized powder formulation, contributing to improve the quality control and to assure the therapeutic efficacy. © The Author [2012]. Published by Oxford University Press. All rights reserved.en
dc.description.affiliationPostgraduate Program in Pharmaceutical Sciences Faculty of Pharmaceutical Sciences of Araraquara UNESP, Araraquara-SP
dc.description.affiliationUnespPostgraduate Program in Pharmaceutical Sciences Faculty of Pharmaceutical Sciences of Araraquara UNESP, Araraquara-SP
dc.format.extent192-199
dc.identifierhttp://dx.doi.org/10.1093/chromsci/bms126
dc.identifier.citationJournal of Chromatographic Science, v. 51, n. 2, p. 192-199, 2013.
dc.identifier.doi10.1093/chromsci/bms126
dc.identifier.issn0021-9665
dc.identifier.scopus2-s2.0-84872715689
dc.identifier.urihttp://hdl.handle.net/11449/74493
dc.identifier.wosWOS:000315172100016
dc.language.isoeng
dc.relation.ispartofJournal of Chromatographic Science
dc.relation.ispartofjcr1.037
dc.relation.ispartofsjr0,360
dc.rights.accessRightsAcesso restrito
dc.sourceScopus
dc.subjectdrug derivative
dc.subjectminocycline
dc.subjecttigecycline
dc.subjectchemistry
dc.subjectdrug stability
dc.subjectlimit of detection
dc.subjectmethodology
dc.subjectpowder
dc.subjectreproducibility
dc.subjectreversed phase liquid chromatography
dc.subjectstandard
dc.subjectstatistical model
dc.subjectChromatography, Reverse-Phase
dc.subjectDrug Stability
dc.subjectLimit of Detection
dc.subjectLinear Models
dc.subjectMinocycline
dc.subjectPowders
dc.subjectReproducibility of Results
dc.titleValidation of a stability-indicating RP-LC method for the determination of tigecycline in lyophilized powderen
dc.typeArtigo
dcterms.licensehttp://www.oxfordjournals.org/access_purchase/self-archiving_policyb.html
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Ciências Farmacêuticas, Araraquarapt

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