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dc.creatorDobričić, Vladimir
dc.creatorVukadinović, Dragana
dc.creatorJančić-Stojanović, Biljana
dc.creatorVladimirov, Sote
dc.creatorČudina, Olivera
dc.date.accessioned2019-09-02T12:02:22Z
dc.date.available2019-09-02T12:02:22Z
dc.date.issued2017
dc.identifier.issn0009-5893
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/3002
dc.description.abstractAnalytical quality by design (AQbD)-oriented liquid chromatographic method development for determination of telmisartan and its impurities A, C, and 1 is determination is presented. Step-by-step process was conducted in order to define reliable design space. At the beginning, critical process parameters with the highest influence on method performance were defined: acetonitrile content in the first (ACN 1) and second (ACN 2) gradient step and time (t (2)) the second gradient step. These factors were varied according to Box-Behnken plan of experiments and their influence on retention times of impurities A and C, S value between telmisartan and impurity 1 and peak capacity were followed. In this way, the relationship between the critical process parameters and critical quality attributes was established. The obtained mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing, and the method was validated to verify the adequacy of selected optimal conditions. Finally, all validation parameters were tested, and adequacy of the method was confirmed. Applicability as a routine method was confirmed by analysis of commercially available tablets.en
dc.publisherSpringer Heidelberg, Heidelberg
dc.relationinfo:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/172041/RS//
dc.rightsrestrictedAccess
dc.sourceChromatographia
dc.subjectLCen
dc.subjectAQbDen
dc.subjectDesign spaceen
dc.subjectTelmisartanen
dc.subjectImpuritiesen
dc.titleAQbD-Oriented Development of a New LC Method for Simultaneous Determination of Telmisartan and Its Impuritiesen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractЈанчић-Стојановић, Биљана; Чудина, Оливера; Владимиров, Соте; Вукадиновић, Драгана; Добричић, Владимир;
dc.citation.volume80
dc.citation.issue8
dc.citation.spage1199
dc.citation.epage1209
dc.citation.other80(8): 1199-1209
dc.citation.rankM23
dc.identifier.wos000406191600006
dc.identifier.doi10.1007/s10337-017-3330-2
dc.identifier.scopus2-s2.0-85020083635
dc.identifier.rcubconv_3899
dc.type.versionpublishedVersion


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