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dc.creatorMasković, M.
dc.creatorJančić-Stojanović, Biljana
dc.creatorMalenović, Anđelija
dc.creatorIvanović, D.
dc.creatorMedenica, Mirjana
dc.date.accessioned2019-09-02T11:21:45Z
dc.date.available2019-09-02T11:21:45Z
dc.date.issued2010
dc.identifier.issn1233-2356
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/1399
dc.description.abstractRobustness testing is an important part of method validation. Many ideas on robustness testing can be found in the literature, but the most useful approach is application of experimental design. In the work discussed in this paper, Plackett-Burman design was used for robustness testing of an LC method. Robustness was assessed for a previously validated method developed for chromatographic analysis of perindopril tert-butylamine and its impurities. Eleven factors (seven real and four dummies) in twelve experiments were examined. Robustness was assessed by graphical (half-normal probability plots and Pareto charts) and statistical (t-test) methods. For estimation of the standard error of effect (necessary for t-test estimation) calculations based on negligible effects and Dong's algorithm were used at the significance levels alpha = 0.05 and alpha = 0.01. In this way the effect of the factors was completely defined and, furthermore, nonsignificant intervals for significant variables were calculated. Finally, on the basis of the worst-case situation, system-suitability tests were performed and acceptance limits for certain values were calculated.en
dc.publisherAkademiai Kiado Zrt, Budapest
dc.relationinfo:eu-repo/grantAgreement/MESTD/MPN2006-2010/142077/RS//
dc.rightsrestrictedAccess
dc.sourceActa Chromatographica
dc.subjectPlackett-Burman designen
dc.subjectrobustnessen
dc.subjectsystem-suitability testsen
dc.subjectperindopril tert-butylamineen
dc.subjectimpuritiesen
dc.subjectliquid chromatographyen
dc.titleAssessment of Liquid Chromatographic Method Robustness by Use of Plackett-Burman Designen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractИвановић, Д.; Меденица, Мирјана; Јанчић-Стојановић, Биљана; Маленовић, Aнђелија; Масковић, М.;
dc.citation.volume22
dc.citation.issue2
dc.citation.spage281
dc.citation.epage296
dc.citation.other22(2): 281-296
dc.citation.rankM23
dc.identifier.wos000279636700010
dc.identifier.doi10.1556/AChrom.22.2010.2.10
dc.identifier.scopus2-s2.0-77952962987
dc.identifier.rcubconv_2325
dc.type.versionpublishedVersion


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