Simple and rapid validated HPLC-fluorescence determination of perampanel in the plasma of patients with epilepsy

摘要

We present a simple and fast high-performance liquid chromatography method with fluorescence detection for the determination of the antiepileptic drug perampanel in human plasma. The chromatographic separation was performed on a Kinetex PFP (100 × 2.6mm, 4.6μm) column, using a mobile phase of sodium acetate 0.03MpH 3.7 and acetonitrile (40/60, v/v), at a flow rate of 0.8mL/min. Total chromatography time for each run was 5min. Sample preparation (250μL) involved only one simple precipitation step by acetonitrile spiked with mirtazapine as internal standard. The method was validated over a concentration range of 20–1000ng/mL and successfully applied to measure perampanel concentrations in plasma samples obtained from patients with epilepsy. This assay combines the high specificity of fluorescence detection with a very simple and fast sample pretreatment and can offer real advantages over existing methods in terms of simplicity and transferability to a therapeutic drug monitoring setting. Highlights ? A very simple assay for the determination of perampanel in human plasma is proposed. ? The analysis is based on HPLC-F coupled with an only deproteinization step. ? No time consuming liquid-liquid extractions and evaporations are required. ? This assay significantly simplifies existing ones in terms of transferability to TDM.