Determinazione del perampanel plasmatico: confronto e cross-validazione tra due metodi in cromatografia liquida ad elevate prestazioni con rivelatore spettrofluorimetrico e con rivelatore a spettrometria di massa

Perampanel (PMP) (2- [2-oxo-1-phenyl-5-pyridin-2-y1-1,2 dihydropyridin-3-y1] benzonitrile hydrate) is a novel non-competitive selective antagonist of the postsynaptic ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) glutamate receptor. In this study, we compared two different methods for the quantification of perampanel in human plasma: a commercially available HPLC kit with fluorescent detector and a kit for determination of 18 different antiepileptic drugs (perampanel excluded) based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) used to implement the perampanel determination. LC-MS/MS method was fully validated according to available guidelines: calibration curves were linear across perampanel concentration range of 2,5-2,800 ng/mL with correlation coefficient >0,99. Accuracy and precision results were in accordance with acceptance criteria (15%). Data collected from 95 patients, treated with perampanel as maintenance antiepileptic therapy, show a very strong correlation between the two methods. Perampanel plasma concentrations in patient samples at steady state, determined with the LC-MS/MS method, ranged from 35 to 985 ng/mL and are in line with previously reported data.