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dc.creatorKasagić-Vujanović, Irena
dc.creatorMalenović, Anđelija
dc.creatorJovanović, Marko
dc.creatorRakić, Tijana
dc.creatorJančić-Stojanović, Biljana
dc.creatorIvanović, Darko
dc.date.accessioned2019-09-02T11:34:19Z
dc.date.available2019-09-02T11:34:19Z
dc.date.issued2013
dc.identifier.issn1330-0075
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/1920
dc.description.abstractThis paper presents the chemometrically assisted optimization and validation of the RP-HPLC method intended for the quantitative analysis of itraconazole and its impurities in pharmaceutical dosage forms. To reach the desired chromatographic resolution with a limited number of experiments in a minimum amount of time, Box-Behnken design was used to simultaneously optimize some important chromatographic parameters, such as the acetonitrile content in the mobile phase, pH of the aqueous phase and the column temperature. Separation between itraconazole and impurity F was identified as critical and selected as a response during the optimization. The set optimal mobile phase composition was acetonitrile/water pH 2.5 adjusted with o-phosphoric acid (50:50, V/V). Separations were performed on a Zorbax Eclipse XDB-C18, 4.6 x 150 mm, 5 mu m particle size column with the flow rate 1 mL min(-1), column temperature set at 30 degrees C and UV detection at 256 nm. The established method was then subjected to method validation and the required validation parameters were tested. For the robustness evaluation, fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. As other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of itraconazole, its impurities B and F in any laboratory under different circumstances has been proven.en
dc.publisherHrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb
dc.relationinfo:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/172052/RS//
dc.rightsopenAccess
dc.sourceActa Pharmaceutica
dc.subjectitraconazoleen
dc.subjectitraconazole impuritiesen
dc.subjecthigh performance liquid chromatographyen
dc.subjectBox-Behnken designen
dc.subjectfractional factorial designen
dc.titleChemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impuritiesen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractКасагић-Вујановић, Ирена; Маленовић, Aнђелија; Јанчић-Стојановић, Биљана; Ивановић, Дарко; Ракић, Тијана; Јовановић, Марко;
dc.citation.volume63
dc.citation.issue2
dc.citation.spage159
dc.citation.epage173
dc.citation.other63(2): 159-173
dc.citation.rankM23
dc.identifier.wos000322286100002
dc.identifier.doi10.2478/acph-2013-0015
dc.identifier.pmid23846140
dc.identifier.scopus2-s2.0-84880796841
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs//bitstream/id/693/1918.pdf
dc.identifier.rcubconv_2792
dc.type.versionpublishedVersion


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