Fluorimetric derivatization-based HPLC-FL method for the prototype pharmacokinetic analysis of selexipag in human plasma

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dc.authorid0000-0003-3666-8187
dc.authorid0000-0002-3401-9186
dc.authorid0000-0002-5840-7386
dc.authorid0000-0001-8455-1173
dc.contributor.authorCeylan, Burhan
dc.contributor.authorÇayci, Meltem
dc.contributor.authorÖnal, Cem
dc.contributor.authorÖnal, Armağan
dc.date.accessioned2025-06-25T12:01:39Z
dc.date.available2025-06-25T12:01:39Z
dc.date.issued2025
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Meslek Bilimleri Bölümü, Analitik Kimya Ana Bilim Dalı
dc.description.abstractA simple and cost-effective HPLC-FL method has been developed for measuring selexipag in human plasma, showcasing its suitability for pharmacokinetic research. Selexipag was precolumn derivatized with 7-chloro-4-nitrobenzofurazan (NBD-Cl) and the fluorescent derivative was separated on a C18 (150 mm × 4.6 mm × 2.6 μm) analytical column at 30 ºC using a mobile phase composed of acetonitrile – 0.1% o-phosphoric acid in water (70:30, v/v) by isocratic elution with flow rate of 1.0 mL min-1. The method was based on measuring the derivative using fluorescence detection (λex = 380 nm, λem = 420 nm). The retention time of selexipag is 6.40 ± 0.01 min. This currently developed method was validated according to EMA criteria by evaluating the specificity, linearity, precision, accuracy, and robustness. The method was determined to be linear in a concentration range of 0.01-20 ng mL-1 with a correlation coefficient of 0.9998. LOD and LOQ were found to be 0.003 and 0.01 ng mL-1, respectively. Intraday and interday RSD values were less than 1.75%. The plasma concentration-time profile and pharmacokinetic parameters such as AUC0–t, AUC0–∞, Cmax, tmax, t1/2, were calculated according to the assays. The presented method can be effectively used for bioequivalence and bioavailability investigations, as well as for routine analysis of the drug in plasma.
dc.identifier.citationCeylan, B., Çayci, M., Önal, C., & Önal, A. (2025). Fluorimetric derivatization-based HPLC-FL method for the prototype pharmacokinetic analysis of selexipag in human plasma. Methods and Objects of Chemical Analysis, 20(2), pp. 117-122. https://doi.org/10.17721/moca.2025.117-122
dc.identifier.doi10.17721/moca.2025.117-122
dc.identifier.endpage122
dc.identifier.issn2413-6166
dc.identifier.issn1991-0290
dc.identifier.issue2
dc.identifier.scopus2-s2.0-105008132814
dc.identifier.scopusqualityQ4
dc.identifier.startpage117
dc.identifier.urihttps://doi.org/10.17721/moca.2025.117-122
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1018
dc.identifier.volume20
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynak.otherESCI - Emerging Sources Citation Index
dc.institutionauthorÖnal, Cem
dc.institutionauthorid0000-0002-5840-7386
dc.language.isoen
dc.publisherTaras Shevchenko National University
dc.relation.ispartofMethods and Objects of Chemical Analysis
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectSelexipag
dc.subjectHPLC-FL
dc.subjectPre-Column Derivatization
dc.subjectPharmacokinetics
dc.subjectNBD-Cl
dc.titleFluorimetric derivatization-based HPLC-FL method for the prototype pharmacokinetic analysis of selexipag in human plasma
dc.typeArticle
dspace.entity.typePublication

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