Fluorescence HPLC analysis of teriflunomide in human plasma following derivatization with 4-chloro-7-nitrobenzofurazan: Method development and application to a prototype pharmacokinetic evaluation

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dc.authorid0000-0002-3401-9186
dc.authorid0000-0003-3666-8187
dc.authorid0000-0002-5840-7386
dc.contributor.authorÇayci, Meltem
dc.contributor.authorCeylan, Burhan
dc.contributor.authorÖnal, Cem
dc.date.accessioned2026-07-24T11:00:52Z
dc.date.available2026-07-24T11:00:52Z
dc.date.issued2026
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Meslek Bilimleri Bölümü, Analitik Kimya Ana Bilim Dalı
dc.description.abstractBackground/Objectives: Teriflunomide is an active metabolite of leflunomide and acts as a selective and reversible inhibitor of dihydroorotate dehydrogenase, a key enzyme in de novo pyrimidine biosynthesis. It exhibits immunomodulatory activity by reducing the proliferation of activated T and B lymphocytes and is widely used in the treatment of rheumatoid arthritis and relapsing multiple sclerosis. This study aimed to develop a rapid, accurate, and simple high-performance liquid chromatography (HPLC) method with fluorometric detection for quantifying teriflunomide in human plasma. Methods: Plasma samples were prepared by liquid–liquid extraction followed by pre-column derivatization with NBD-Cl. Teriflunomide was derivatized with 4-chloro-7-nitrobenzofurazan (NBD-Cl) and separated using a reversed-phase C18 column (5 µm, 4.6 × 150 mm) at 30 ◦C with isocratic elution. The mobile phase consisted of acetonitrile and 0.1% orthophosphoric acid (80:20, v/v) at a flow rate of 1.1 mL/min. Fluorescence detection was performed at λex = 465 nm and λem = 535nm. ThemethodmeetsEuropean Medicines Agency (EMA) guide lines for bioanalytical validation and was successfully applied to pharmacokinetic studies, including AUC0–t, AUC0–∞, Cmax, Tmax, and t½. Results: Teriflunomide showed a retention time of 2.55 ± 0.01 min. The method exhibited linearity in the range of 0.01–30 ng/mL (r2 = 0.9998), with a limit of detection and quantification of 0.003 and 0.01 ng/mL, respec tively. The relative standard deviation was 3.27%. Conclusions: This work introduces a novel, cost-effective, and highly sensitive HPLC with fluorescence detection (HPLC-FL) method for the determination of teriflunomide in human plasma, providing an efficient alternative to LC-MS/MS for routine pharmacokinetic and bioequivalence studies.
dc.identifier.citationÇayci, M., Ceylan, B., & Önal, C. (2026). Fluorescence HPLC analysis of teriflunomide in human plasma following derivatization with 4-chloro-7-nitrobenzofurazan: Method development and application to a prototype pharmacokinetic evaluation. Pharmaceuticals, 19(7), pp. 1-12. https://doi.org/10.3390/ph19070987
dc.identifier.doi10.3390/ph19070987
dc.identifier.endpage12
dc.identifier.issn1424-8247
dc.identifier.issue7
dc.identifier.pmidPMID: 42515675
dc.identifier.scopus2-s2.0-105045888457
dc.identifier.scopusqualityQ1
dc.identifier.startpage1
dc.identifier.urihttps://doi.org/10.3390/ph19070987
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1556
dc.identifier.volume19
dc.identifier.wosWOS:001831846500001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.indekslendigikaynak.otherSCI-E - Science Citation Index Expanded
dc.institutionauthorÖnal, Cem
dc.institutionauthorid0000-0002-5840-7386
dc.language.isoen
dc.publisherMDPI Publishing
dc.relation.ispartofPharmaceuticals
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectTeriflunomide
dc.subjectHPLC-FL
dc.subjectPre-Column Derivatization
dc.subjectValidation
dc.subjectPharmacokinetics
dc.titleFluorescence HPLC analysis of teriflunomide in human plasma following derivatization with 4-chloro-7-nitrobenzofurazan: Method development and application to a prototype pharmacokinetic evaluation
dc.typeArticle
dspace.entity.typePublication

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