Simultaneous determination of eight antiepileptic drugs and two metabolites in human plasma by liquid chromatography/tandem mass spectrometry

• Autorzy: Yu Hengyi , Ren Xiuhua , Liu Lu , Xiang Dong , Li Xiping , Li Juan , Liu Dong , Gong Xuepeng

Identyfikatory

DOI

10.1556/1326.2022.01024

• Języki publikacji: EN

Abstrakty

EN

Epilepsy is one of the most prevalent neurological conditions and antiepileptic drugs are the mainstay of epilepsy treatment. High variation in pharmacokinetic profiles of several antiepileptic drugs highlights the importance of therapeutic drug monitoring to estimate pharmacokinetic properties and consequently individualize drug posology. In this work, a simple, rapid and robust liquid chromatography-tandem mass spectrometry method was developed for simultaneous quantification of carbamazepine and its metabolite carbamazepine-10,11-epoxide, gabapentin, levetiracetam, lamotrigine, oxcarbazepine and its metabolite mono-hydroxy-derivative metabolite, phenytoin, topiramate, and valproic acid in human plasma for therapeutic drug monitoring. d₆-Levetiracetam, d₄-gabapentin and d₆-valproic acid were used as internal standards. After addition of internal standards along with two-step protein precipitation and dilution sample preparation, plasma samples were analyzed on a C₁₈ column using a gradient elution in 5 min without interference. The calibration curves were linear over a 100-fold concentration range, with determination coefficients (r²) greater than 0.99 for all analytes. The limit of quantification was 0.5 μg mL⁻¹ (0.1 μg mL⁻¹ for oxcarbazepine, 2 μg mL⁻¹ for levetiracetam, and 10 μg mL⁻¹ for valproic acid) with precision and accuracy ranging from 3% to 9% and from 94% to 112%, respectively. Intra- and inter-day precision and accuracy values were within 15% at low, medium and high quality control levels. No significant matrix effect was observed in the normal, hemolyzed, lipemic, and hyperbilirubin blood samples. This method was successfully used in the identification and quantitation of antiepileptic drugs in patients undergoing mono- or polytherapy for epilepsy.

Słowa kluczowe

EN

antiepileptic drugs; therapeutic drug monitoring; LC-MS/MS; human plasma

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 2
• Strony: 161--169
• Opis fizyczny: Bibliogr. 18 poz., rys., tab., wykr.

Twórcy

autor

Yu Hengyi

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

• https://orcid.org/0000-0002-5412-5293

autor

Ren Xiuhua

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

autor

Liu Lu

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

autor

Xiang Dong

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

autor

Li Xiping

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

autor

Li Juan

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

autor

Liu Dong

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

• https://orcid.org/0000-0002-2928-3548

autor

Gong Xuepeng

• Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

• https://orcid.org/0000-0003-0099-2938

Bibliografia

• 1. Cendes, F. Lancet Neurol. 2021, 20, 333–4.
• 2. Wang, Y.; Chen, Z. Pharmacol. Ther. 2019, 201, 77–93.
• 3. Hiemke, C.; Bergemann, N.; Clement, H. W.; Conca, A.; Deckert, J.; Domschke, K.; Eckermann, G.; Egberts, K.; Gerlach, M.; Greiner, C.; Grunder, G.; Haen, E.; Havemann-Reinecke, U.; Hefner, G.; Helmer, R.; Janssen, G.; Jaquenoud, E.; Laux, G.; Messer, T.; Mossner, R.; Muller, M. J.; Paulzen, M.; Pfuhlmann, B.; Riederer, P.; Saria, A.; Schoppek, B.; Schoretsanitis, G.; Schwarz, M.; Gracia, M. S.; Stegmann, B.; Steimer, W.; Stingl, J. C.; Uhr, M.; Ulrich, S.; Unterecker, S.; Waschgler, R.; Zernig, G.; Zurek, G.; Baumann, P. Pharmacopsychiatry 2018, 51, 9–62.
• 4. Hiemke, C.; Baumann, P.; Bergemann, N.; Conca, A.; Dietmaier, O.; Egberts, K.; Fric, M.; Gerlach, M.; Greiner, C.; Grunder, G.; Haen, E.; Havemann-Reinecke, U.; Jaquenoud, S. E.; Kirchherr, H.; Laux, G.; Lutz, U. C.; Messer, T.; Muller, M. J.; Pfuhlmann, B.; Rambeck, B.; Riederer, P.; Schoppek, B.; Stingl, J.; Uhr, M.; Ulrich, S.; Waschgler, R.; Zernig, G. Pharmacopsychiatry 2011, 44, 195–235.
• 5. Jarvie, D.; Mahmoud, S. H. J. Pharm. Pharm. Sci. 2018, 21, 149s–76s.
• 6. Dasgupta, A.; McNeese, C.; Wells, A. Am. J. Clin. Pathol. 2004, 121, 418–25.
• 7. McMillin, G. A.; Juenke, J. M.; Tso, G.; Dasgupta, A. Am. J. Clin. Pathol. 2010, 133, 728–36.
• 8. Juenke, J. M.; Brown, P. I.; Johnson-Davis, K. L.; McMillin, G. A. Ther. Drug Monit. 2011, 33, 209–13.
• 9. Yin, L.; Wang, T.; Shi, M.; Zhang, Y.; Zhao, X.; Yang, Y.; Gu, J. J. Sep. Sci. 2016, 39, 964–72.
• 10. Subramanian, M.; Birnbaum, A. K.; Remmel, R. P. Ther. Drug Monit. 2008, 30, 347–56.
• 11. Deeb, S.; McKeown, D. A.; Torrance, H. J.; Wylie, F. M.; Logan, B. K.; Scott, K. S. J. Anal. Toxicol. 2014, 38, 485–94.
• 12. Shibata, M.; Hashi, S.; Nakanishi, H.; Masuda, S.; Katsura, T.; Yano, I. Biomed. Chromatogr. 2012, 26, 1519–28.
• 13. Kim, K. B.; Seo, K. A.; Kim, S. E.; Bae, S. K.; Kim, D. H.; Shin, J. G. J. Pharm. Biomed. Anal. 2011, 56, 771–7.
• 14. Liu, T.; Kotha, R. R.; Jones, J. W.; Polli, J. E.; Kane, M. A. J. Pharm. Biomed. Anal. 2019, 176, 112816.
• 15. Qi, Y.; Liu, G. Biomed. Chromatogr. 2021, 35, e5090.
• 16. FDA. Bioanalytical Method Validation Guidance for Industry, 2018.
• 17. Corso, G.; D’Apolito, O.; Paglia, G. Rapid Commun. Mass Spectrom. 2007, 21, 269–72.
• 18. Dupouey, J.; Doudka, N.; Belo, S.; Blin, O.; Guilhaumou, R. Biomed. Chromatogr. 2016, 30, 2053–60.