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Quantification of the Plasma Concentrations of Perampanel Using High-Performance Liquid Chromatography and Effects of the CYP3A4*1G Polymorphism in Japanese Patients.
Ohkubo, Sho; Akamine, Yumiko; Ohkubo, Tadashi; Kikuchi, Yuka; Miura, Masatomo.
Afiliación
  • Ohkubo S; Department of Pharmacy, Akita University Hospital, Akita, Japan.
  • Akamine Y; Department of Pharmacy, Akita University Hospital, Akita, Japan.
  • Ohkubo T; Research Institute of Shichifuku Pharmacy, Aomori, Japan.
  • Kikuchi Y; Department of Neuropsychiatry, Akita University Graduate School of Medicine, Akita, Japan.
  • Miura M; Department of Pharmacy, Akita University Hospital, Akita, Japan.
J Chromatogr Sci ; 58(10): 915-921, 2020 Oct 26.
Article en En | MEDLINE | ID: mdl-32888296
Here, we developed a novel high-performance liquid chromatography (HPLC) method for quantification of perampanel in clinical practice and investigated the relationships between the plasma concentrations of perampanel obtained by this HPLC method and the CYP3A4*1G polymorphism. The developed HPLC method was validated based on US Food and Drug Administration. The developed HPLC method could be performed with a plasma volume of only 200 µL and had a limit of quantification (LOQ) of 2.5 ng/mL. The coefficients of variation (CVs) for intra- and inter-day assays were less than 10.4 and 7.2%, respectively, and the accuracy was <2.4% for both assays. A total of 12 patients who received 2 mg perampanel had C0 values ranging from 70.5 to 451 ng/mL, and the CV showed a large variation of 51.4%. No correlations were observed between the dose-adjusted C0 and the CYP3A4*1G polymorphism. This method was superior to previously reported methods in terms of plasma volume and LOQ and was clinically applicable. Perampanel showed high variations in individual plasma concentrations; however, individual differences could not be predicted from analysis of the CYP3A4*1G polymorphism before perampanel administration. Therefore, after beginning perampanel treatment, the dose should be determined based on the observed plasma concentration.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piridonas / Cromatografía Líquida de Alta Presión / Citocromo P-450 CYP3A Tipo de estudio: Prognostic_studies Límite: Adult / Female / Humans / Male País/Región como asunto: Asia Idioma: En Revista: J Chromatogr Sci Año: 2020 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piridonas / Cromatografía Líquida de Alta Presión / Citocromo P-450 CYP3A Tipo de estudio: Prognostic_studies Límite: Adult / Female / Humans / Male País/Región como asunto: Asia Idioma: En Revista: J Chromatogr Sci Año: 2020 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos