Determination of Perampanel Concentration in Human Plasma by HPLC and Its Clinical Application in Pediatrics

OBJECTIVE To establish an HPLC method for the determination of perampanel concentration in human plasma.METHODS The plasma samples were separated on an Agilent ZORBAX SB-C₁₈(4.6 mm×150 mm, 5 μm) column using a mobile phase of 0.05% orthophosphoric acid(pH 3.5)-acetonitrile(56:44) at a flow rate of 1 mL·min^-1. The column temperature was 30℃, and detection wavelength was 290 nm. Perampanel concentration in children with epilepsy and investigation of risk factors affecting blood concentration was determined. RESULTS The linear range of perampanel was 75-2 500 μg·L^-1, and the limit of quantitation was 75 μg·L^-1. The accuracy didn't exceed ±10% of the marked value, the precision was less than 5%, and the recovery was 97.6%-101.0%. The samples were stable at the different conditions detected. A total 51 plasma samples of children diagnosed with epilepsy were measured by the established method, and the trough concentrations of perampanel were 91.6-1 681.9 μg·L^-1. Age influenced the perampanel concentrations, the concentrations of patients younger than 5 years old was significantly lower than that aged 5-12 years, but no significant difference was found when compared with that aged older than 12 years and younger than 5 years. CONCLUSION The method is simple, accurate, sensitive and can be used for the therapeutic drug monitoring of perampanel in clinic. The age of patients has a significant impact on the trough concentrations of perampanel.