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dc.creatorMasković, Marija
dc.creatorDotsikas, Yannis
dc.creatorMalenović, Anđelija
dc.creatorJančić-Stojanović, Biljana
dc.creatorIvanović, Darko
dc.creatorMedenica, Mirjana
dc.date.accessioned2019-09-02T11:25:28Z
dc.date.available2019-09-02T11:25:28Z
dc.date.issued2011
dc.identifier.issn1060-3271
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/1560
dc.description.abstractThis paper describes the development and validation of a microemulsion liquid chromatography (MELC) method for simultaneous determination of perindopril tert-butylamine and its impurities in bulk active substances and the pharmaceutical dosage form of tablets. An appropriate resolution with reasonable retention times was obtained for a microemulsion containing 0.24% (w/v) butyl acetate, 0.30% (w/v) ethyl acetate, 2% (w/v) sodium dodecyl sulfate, 7.75% (w/v) n-butanol, and 20.0 mM potassium dihydrogen phosphate, the pH of which was adjusted to 3.70 with 85% orthophosphoric acid. Separations were performed on a Nucleosil 120-5 butyl modified (C4), 250 x 4 mm, 5 pm particle size silica column at 40 degrees C, with a mobile phase flow rate of 1.25 mL/min. UV detection was performed at 254 nm. The established method was subjected to method validation, and required validation parameters were defined. Robustness testing, an important part of method validation, was performed as well. Since robustness validation can be conducted using different experimental designs, the Plackett-Burman design was applied due to its possibility of testing many factors at the same time. The validated MELC method was found to be suitable for the simultaneous determination of perindopril tert-butylamine and its impurities in pharmaceuticals.en
dc.publisherAOAC Int, Gaithersburg
dc.relationinfo:eu-repo/grantAgreement/MESTD/MPN2006-2010/142077/RS//
dc.rightsrestrictedAccess
dc.sourceJournal of AOAC International
dc.titleValidation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impuritiesen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractИвановић, Дарко; Меденица, Мирјана; Маленовић, Aнђелија; Масковић, Марија; Дотсикас, Yаннис; Јанчић-Стојановић, Биљана;
dc.citation.volume94
dc.citation.issue3
dc.citation.spage723
dc.citation.epage734
dc.citation.other94(3): 723-734
dc.citation.rankM22
dc.identifier.wos000291775400005
dc.identifier.pmid21796999
dc.identifier.scopus2-s2.0-80051933606
dc.identifier.rcubconv_2458
dc.type.versionpublishedVersion


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