Simple HPLC-UV method for therapeutic drug monitoring of 12 antiepileptic drugs and their main metabolites in human plasma

Milosheska, Daniela (avtor), Roškar, Robert (avtor)

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.

• Jezik: Angleški jezik
• Ključne besede: antiepileptic drugs, human plasma, therapeutic drug monitoring, bioanalytical method validation, high-performance liquid chromatography
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2023
• Št. strani: 15 str.
• Številčenje: Vol. 28, iss. 23, art. 7830
• PID: 20.500.12556/RUL-152740
• UDK: 543.544.5:616.853
• ISSN pri članku: 1420-3049
• DOI: 10.3390/molecules28237830
• COBISS.SI-ID: 174900739
• Datum objave v RUL: 05.12.2023

Gradivo je del revije

• Naslov: Molecules
• Skrajšan naslov: Molecules
• Založnik: MDPI
• ISSN: 1420-3049
• COBISS.SI-ID: 18462981

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: antiepileptična zdravila, človeška plazma, terapevtsko spremljanje zdravil, validacija bioanalitskih metod, tekočinska kromatografija visoke ločljivosti, epilepsija

Projekti

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P1-0189
• Naslov: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

• Financer: Drugi - Drug financer ali več financerjev
• Program financ.: AD Futura Science and Education Foundation of the Republic of Slovenia