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dc.creatorJovanović, Marko
dc.creatorRakić, Tijana
dc.creatorTumpa, Anja
dc.creatorJančić-Stojanović, Biljana
dc.date.accessioned2019-09-02T11:46:57Z
dc.date.available2019-09-02T11:46:57Z
dc.date.issued2015
dc.identifier.issn0731-7085
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2398
dc.description.abstractThis study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm.en
dc.publisherElsevier Science BV, Amsterdam
dc.relationinfo:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/172052/RS//
dc.rightsrestrictedAccess
dc.sourceJournal of Pharmaceutical and Biomedical Analysis
dc.subjectQuality by Designen
dc.subjectDesign spaceen
dc.subjectIohexolen
dc.subjectImpuritiesen
dc.subjectHILICen
dc.titleQuality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impuritiesen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractЈанчић-Стојановић, Биљана; Јовановић, Марко; Ракић, Тијана; Тумпа, Aња;
dc.citation.volume110
dc.citation.spage42
dc.citation.epage48
dc.citation.other110: 42-48
dc.citation.rankM21
dc.description.otherPeer-reviewed manuscript: [http://farfar.pharmacy.bg.ac.rs/handle/123456789/3418]
dc.identifier.wos000353610800006
dc.identifier.doi10.1016/j.jpba.2015.02.046
dc.identifier.pmid25796982
dc.identifier.scopus2-s2.0-84924933726
dc.identifier.rcubconv_3299
dc.type.versionpublishedVersion


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