Daniela Milosheska (Author), Robert Roškar (Author)

Abstract

The objective of the present report was to develop and validate a simple, selective, and reproducible high-performance liquid chromatography method with UV detection suitable for routine therapeutic drug monitoring of the most commonly used antiepileptic drugs and some of their metabolites. Simple precipitation of plasma proteins with acetonitrile was used for sample preparation. 10,11-dihydrocarbamazepine was used as an internal standard. Chromatographic separation of the analytes was achieved by gradient elution on a Phenyl–Hexyl column at 40 °C, using methanol and potassium phosphate buffer (25 mM; pH 5.1) as a mobile phase. The method was validated according to the FDA guidelines for bioanalytical method validation. It showed to be selective, accurate, precise, and linear over the concentration ranges of 1–50 mg/L for phenobarbital, phenytoin, levetiracetam, rufinamide, zonisamide, and lacosamide; 0.5–50 mg/L for lamotrigine, primidone, carbamazepine and 10-monohydroxycarbazepine; 0.2–10 mg/L for carbamazepine metabolites: 10,11-trans-dihydroxy-10,11-dihydrocarbamazepine and carbamazepine-10,11-epoxide; 0.1–10 mg/L for oxcarbazepine; 2–100 mg/L for felbamate and 3–150 mg/L for ethosuximide. The suitability of the validated method for routine therapeutic drug monitoring was confirmed by quantification of the analytes in plasma samples from patients with epilepsy on combination antiepileptic therapy.

Keywords

antiepileptična zdravila;človeška plazma;terapevtsko spremljanje zdravil;validacija bioanalitskih metod;tekočinska kromatografija visoke ločljivosti;antiepileptic drugs;human plasma;therapeutic drug monitoring;bioanalytical method validation;high-performance liquid chromatography;

Data

Language: English
Year of publishing:
Typology: 1.01 - Original Scientific Article
Organization: UL FFA - Faculty of Pharmacy
UDC: 543.544.5:616.853
COBISS: 174900739 Link will open in a new window
ISSN: 1420-3049
Views: 6
Downloads: 0
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Other data

Secondary language: Slovenian
Secondary keywords: Tekočinska kromatografija;Epilepsija;
Type (COBISS): Article
Pages: 15 str.
Volume: ǂVol. ǂ28
Issue: ǂiss. ǂ23, [article no.] 7830
Chronology: 2023
DOI: 10.3390/molecules28237830
ID: 21465712