title: Simple and sensitive high performance liquid chromatography method with fluorescence detection for therapeutic drug monitoring of topiramate.
abstract: A simple, sensitive, accurate, precise and inexpensive HPLC method with fluorescence detection, suitable for routine therapeutic drug monitoring (TDM) of an antiepileptic drug topiramate, was developed and validated. The determination of plasma topiramate concentration was carried out after precolumn derivatization, using 4-chloro-7-nitrobenzofurazan as a fluorescent labeling agent and bendroflumethiazide as an internal standard. The standard calibration curve was linear over the concentration range of 0.01-24 μg/mL (r² > 0.9998). The intra- and inter-day accuracies expressed as bias were from 1.4 to 9.9% and from 1.9 to 10.2%, respectively. The intra- and inter-day precisions were below 7.9% and 2.7%, respectively. The validated method was applied for the measurement of plasma topiramate concentrations in patients with epilepsy. The reported method is appropriate for TDM of topiramate as well as for pharmacokinetic and bioequivalence studies.
authors.forename: Daniela
authors.initials: D
authors.lastname: Milosheska
authors.forename: Tomaž
authors.initials: T
authors.lastname: Vovk
authors.forename: Iztok
authors.initials: I
authors.lastname: Grabnar
authors.forename: Robert
authors.initials: R
authors.lastname: Roškar
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D016903:Drug Monitoring; D005632:Fructose / Q000031:analogs & derivatives* / Q000097:blood; D006801:Humans; D013050:Spectrometry, Fluorescence; D000077236:Topiramate
chemical_list: D000077236:Topiramate; D005632:Fructose