Development of an HPLC method for the determination of fampridine (dalfampridine) in human plasma by fluorimetric derivatization and application to a prototype pharmacokinetic study
| dc.authorid | 0000-0003-3666-8187 | |
| dc.authorid | 0000-0002-5840-7386 | |
| dc.authorid | 0000-0001-8455-1173 | |
| dc.contributor.author | Ceylan, Burhan | |
| dc.contributor.author | Önal, Cem | |
| dc.contributor.author | Önal, Armağan | |
| dc.date.accessioned | 2025-06-26T07:58:42Z | |
| dc.date.available | 2025-06-26T07:58:42Z | |
| dc.date.issued | 2025 | |
| dc.department | Fakülteler, Eczacılık Fakültesi, Eczacılık Meslek Bilimleri Bölümü, Analitik Kimya Ana Bilim Dalı | |
| dc.description.abstract | Fampridine (dalfampridine) is used to improve walking in people who have multiple sclerosis. In this study, a new, fast and sensitive HPLC method with fluorometric detection was developed for the determination of fampridine in human plasma and applied to a pharmacokinetic study. Fampridine was precolumn derivatized with 7-chloro-4-nitrobenzofurazan (NBD-Cl) and the fluorescent derivative was separated on a C18 (150 × 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 (80:20, v/v) by isocratic elution with flow rate of 1.0 mL min–1 . The method was based on the measurement of the derivative using fluorescence detection (λex= 310 nm, λem = 365 nm). The retention time of fampridine is 4.10 ± 0.02 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 the correlation coefficient of 0.9996. LOD and LOQ were found to be 0.003 and 0.01 ng mL–1 , respectively. Intraday and interday RSD values were less than 2.45%. 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 certainly be used for bioequivalence and bioavailability investigations and routine analysis of the drug in plasma. | |
| dc.identifier.citation | Ceylan, B., Önal, C., & Önal, A. (2025). Development of an HPLC method for the determination of fampridine (dalfampridine) in human plasma by fluorimetric derivatization and application to a prototype pharmacokinetic study. Revue Roumaine de Chimie, 70(3-4), pp. 215-222. https://doi.org/10.33224/rrch.2025.70.3-4.09 | |
| dc.identifier.doi | 10.33224/rrch.2025.70.3-4.09 | |
| dc.identifier.endpage | 222 | |
| dc.identifier.issn | 0035-3930 | |
| dc.identifier.issue | 3-4 | |
| dc.identifier.scopus | 2-s2.0-105007661632 | |
| dc.identifier.scopusquality | Q4 | |
| dc.identifier.startpage | 215 | |
| dc.identifier.uri | https://doi.org/10.33224/rrch.2025.70.3-4.09 | |
| dc.identifier.uri | https://hdl.handle.net/20.500.13055/1021 | |
| dc.identifier.volume | 70 | |
| dc.identifier.wos | WOS:001507319500009 | |
| dc.identifier.wosquality | Q4 | |
| dc.indekslendigikaynak | Web of Science | |
| dc.indekslendigikaynak | Scopus | |
| dc.indekslendigikaynak | PubMed | |
| dc.indekslendigikaynak.other | SCI-E - Science Citation Index Expanded | |
| dc.institutionauthor | Önal, Cem | |
| dc.institutionauthorid | 0000-0002-5840-7386 | |
| dc.language.iso | en | |
| dc.publisher | Editions de l'Academie Republique Populaire | |
| dc.relation.ispartof | Revue Roumaine de Chimie | |
| dc.relation.publicationcategory | Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı | |
| dc.rights | info:eu-repo/semantics/openAccess | |
| dc.subject | Fampridine | |
| dc.subject | HPLC-FL | |
| dc.subject | Pre-Column Derivatization | |
| dc.subject | Pharmacokinetic | |
| dc.subject | NBD-Cl | |
| dc.title | Development of an HPLC method for the determination of fampridine (dalfampridine) in human plasma by fluorimetric derivatization and application to a prototype pharmacokinetic study | |
| dc.type | Article | |
| dspace.entity.type | Publication |
