Show simple item record

dc.creatorJančić-Stojanović, Biljana
dc.creatorRakić, Tijana
dc.creatorSlavković, B
dc.creatorKostić, Nada
dc.creatorVemić, Ana
dc.creatorMalenović, Anđelija
dc.date.accessioned2019-09-02T11:37:09Z
dc.date.available2019-09-02T11:37:09Z
dc.date.issued2013
dc.identifier.issn2095-1779
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2025
dc.description.abstractMethod validation presents a detailed investigation of analytical method and provision of the evidence that the method, when correctly applied, produces results that fit to the purpose. In order to achieve the method validation scope efficiently, experimental design presents a very useful tool. The greatest benefits of such approach could be seen in robustness testing through the provision of very useful data about the control of the chromatographic system during the routine application. In this paper, robustness testing of the LC method proposed for the determination of raloxifene hydrochloride and its four impurities was done employing Plackett-Burman design. Applying this design, the effect of five real factors (acetonitrile content, sodium dodecyl sulfate content, column temperature, pH of the mobile phase and flow rate) on the corresponding resolution factors was investigated through twelve experiments. Furthermore, the insignificance intervals for significant factors were calculated and the parameters for system suitability tests were defined. Eventually, the other validation parameters were tested and the effectiveness of the proposed analytical method with a high degree of accuracy was confirmed.en
dc.publisherXi'an Jiaotong University
dc.relationinfo:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/172052/RS//
dc.rightsopenAccess
dc.sourceJournal of Pharmaceutical Analysis
dc.subjectExperimental designen
dc.subjectImpuritiesen
dc.subjectLiquid chromatographyen
dc.subjectMethod validationen
dc.subjectRaloxifene hydrochlorideen
dc.titleSystematical approach in evaluation of LC method for determination of raloxifene hydrochloride and its impurities employing experimental designen
dc.typearticle
dc.rights.licenseBY-NC-ND
dcterms.abstractРакић, Тијана; Костић, Нада; Јанчић-Стојановић, Биљана; Славковић, Б; Маленовић, Aнђелија; Вемић, Aна;
dc.citation.volume3
dc.citation.issue1
dc.citation.spage45
dc.citation.epage52
dc.citation.other3(1): 45-52
dc.identifier.doi10.1016/j.jpha.2012.09.007
dc.identifier.scopus2-s2.0-84925837053
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs//bitstream/id/781/2023.pdf
dc.identifier.rcubconv_4828
dc.type.versionpublishedVersion


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record