Development of a novel hplc method for the determination of axitinib in human plasma based on fluorimetric detection and precolumn derivatization with 7-chloro-4-nitrobenzofurazan: Application to a prototype pharmacokinetic study

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dc.authorid0000-0003-3666-8187
dc.authorid0000-0002-5840-7386
dc.authorid0000-0001-8455-1173
dc.contributor.authorCeylan, Burhan
dc.contributor.authorÖnal, Cem
dc.contributor.authorÖnal, Armağan
dc.date.accessioned2026-11-06T12:30:43Z
dc.date.available2026-11-06T12:30:43Z
dc.date.issued2026
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Meslek Bilimleri Bölümü, Analitik Kimya Ana Bilim Dalı
dc.description.abstractTyrosine kinase inhibitors (TKIs) are central to modern targeted cancer therapy. Axitinib, a highly selective oral TKI, primarily inhibits angiogenesis. This study aimed to develop a fast, reliable, and simple HPLC method with fluorescence detection to measure axitinib in human plasma. Sample preparation was performed using a simple and efficient liquid-liquid extraction (LLE) procedure. Axitinib was isolated from alkalinized plasma using chloroform, followed by evaporation of the organic phase. Prior to analysis, axitinib was derivatized with 7-chloro-4-nitrobenzofurazan (NBD-Cl). Separation was performed on a reversed-phase C18 column (2.6 µm, 4.6 mm × 150 mm) at 30 °C under isocratic conditions, using a mobile phase of acetonitrile and 0.1% orthophosphoric acid (75:25 v/v) at 0.9 mL min⁻¹. Fluorescence detection was set at 330 nm excitation and 405 nm emission. Axitinib eluted at 3.15 ± 0.02 minutes. The method showed excellent linearity from 0.01 to 30 ng mL⁻¹ (r = 0.9998), with LOD and LOQ of 0.003 ng mL⁻¹ and 0.01 ng mL⁻¹, respectively. Precision, expressed as RSD, did not exceed 2.65%. Validation confirmed compliance with EMA bioanalytical guidelines. The method was successfully applied in pharmacokinetic studies, enabling determination of AUC₀–t, AUC₀–∞, Cmax, Tmax, and t½. Thanks to its sensitivity and robustness, this HPLC fluorescence method is suitable for routine quantification of axitinib in human plasma and can be applied in bioavailability and bioequivalence studies.
dc.identifier.citationCeylan, B., Önal, C., & Önal, A. (2026). Development of a novel hplc method for the determination of axitinib in human plasma based on fluorimetric detection and precolumn derivatization with 7-chloro-4-nitrobenzofurazan: Application to a prototype pharmacokinetic study. Revue Roumaine de Chimie 71(5-6), pp. 389-397. https://doi.org/10.33224/rrch.2026.71.5-6.09
dc.identifier.doi10.33224/rrch.2026.71.5-6.09
dc.identifier.endpage397
dc.identifier.issn0035-3930
dc.identifier.issue5-6
dc.identifier.scopusqualityQ4
dc.identifier.startpage389
dc.identifier.urihttps://doi.org/10.33224/rrch.2026.71.5-6.09
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1697
dc.identifier.volume71
dc.identifier.wosqualityQ4
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.publisherEditions de l'Academie Republique Populaire
dc.relation.ispartofRevue Roumaine de Chimie
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleDevelopment of a novel hplc method for the determination of axitinib in human plasma based on fluorimetric detection and precolumn derivatization with 7-chloro-4-nitrobenzofurazan: Application to a prototype pharmacokinetic study
dc.typeArticle
dspace.entity.typePublication

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