Therapeutic Salivary Monitoring of Perampanel in Patients with Epilepsy Using a Volumetric Absorptive Microsampling Technique

Introduction This database includes the raw data linked with the paper “ Therapeutic Salivary Monitoring of Perampanel in Patients with Epilepsy Using a Volumetric Absorptive Microsampling Technique” published in “pharmaceutics”. The present work describes the development and validation of a volumetric absorptive microsampling (VAMS) method combined with liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for the quantitative determination of the antiseizure medication perampanel in oral fluid and its clinical applicability in patients with epilepsy. VAMS tips were loaded with 30 μL of oral fluid, dried for 60 minutes and placed into clean tubes. Analytes were extracted with methanol and the samples were incubated at 50°C, sonicated and centrifuged. The supernatant was evaporated at room temperature under a gentle stream of nitrogen and reconstituted with 60 μL of methanol. Separation and quantification were achieved on a monolithic column connected to a mass spectrometer. Calibration curves were linear between 0.5 and 300 ng/mL. Intra- and inter-day accuracy was within 85.6-103.2% and intra-day and inter-day precision did not exceed 12.1%. Mean extraction recoveries ranged from 81.3% to 98.7%. Perampanel was stable in samples collected by VAMS and stored under different storage conditions. The developed VAMS-LC-MS/MS method was validated according to internationally accepted criteria and showed adequate bioanalytical performances holding great potential as alternative strategy to support domiciliary TDM in patients with epilepsy treated with perampanel according to the simplicity of samples collection.引言 本数据库收录了与发表于《Pharmaceutics》期刊的论文《应用体积吸收微量取样技术对癫痫患者体内吡仑帕奈进行治疗性唾液监测》相关的原始数据。本研究阐述了一种结合液相色谱-串联质谱法（liquid chromatography coupled to tandem mass spectrometry, LC-MS/MS）的体积吸收微量取样（volumetric absorptive microsampling, VAMS）方法的开发与验证过程，该方法可定量测定口腔液中的抗癫痫药物吡仑帕奈，并探讨了其在癫痫患者中的临床应用价值。VAMS采样头装载30 μL口腔液后，经60分钟干燥处理，置于洁净离心管中。采用甲醇对分析物进行萃取，随后将样品置于50℃条件下孵育、超声处理并离心。上清液于室温下在温和氮气流中蒸发，再用60 μL甲醇复溶。采用连接至质谱仪的整体柱完成分离与定量分析。校准曲线在0.5~300 ng/mL范围内呈良好线性。日内及日间准确度介于85.6%~103.2%之间，日内及日间精密度均不超过12.1%。平均萃取回收率为81.3%~98.7%。经VAMS采集的样品在不同储存条件下均保持吡仑帕奈的稳定性。本研究所开发的VAMS-LC-MS/MS方法依据国际公认标准完成验证，展现出优异的生物分析性能；鉴于其样品采集简便的优势，该方法有望成为支持接受吡仑帕奈治疗的癫痫患者居家治疗药物监测（therapeutic drug monitoring, TDM）的替代方案。