Development and application of a novel LC-MS/MS method for human plasma concentration monitoring of perampanel in pediatric epilepsy patients.

This study has developed and validated a novel LC-MS/MS assay method to quantify perampanel in pediatric patients with epilepsy in Xinjiang, China. Our assay reduces current specimen volume requirements and decreases the turnaround time for results. Samples were separated by gradient elution and then injected into the mass spectrometer with a total run time of 3 min per sample. The ions from the analytes were detected using multiple reactions by monitoring transitions of m/z 350.2-219.0 for perampanel and m/z 359.1-323.1 for the internal standard, as precursor ion and product ion, respectively. The peak area ratios of perampanel with internal standard within the plasma samples were linear in the concentration range of 0.1-3.2 μg/mL (y = 2.87x + 0.61; r  ≥ 0.99). The within-run and between-run precision coefficient of variation (%) did not exceed 11.03%, and the accuracy (bias) ranged from -1.07 to 6.69%. The mean absolute recoveries of perampanel for four QC levels (lower limit of quantification, low quality control, middle quality control, and high quality control) determined by this method were 87.69, 94.04, 107.50, and 95.15%, respectively. The stability results for this method showed that the plasma samples of perampanel were stable under all tested conditions (86.43-104.81%), with a coefficient of variation (%) maximum of 8.74%.