HPLC测定人血浆中吡仑帕奈的浓度及其儿科临床应用  

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

作　　者：王君燕 王慧娟[1] 张慧芬[1] 何铠锋 缪静 WANG Junyan;WANG Huijuan;ZHANG Huifen;HE Kaifeng;MIAO Jing(Department of Pharmacy,The Children’s Hospital,Zhejiang University School of Medicine,National Clinical Research Center for Child Health,Hangzhou 310052,China)

机构地区：[1]浙江大学医学院附属儿童医院药剂科,国家儿童健康与疾病临床医学研究中心,杭州310052

出　　处：《中国现代应用药学》2022年第12期1580-1584,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省药学会医院药学专项科研资助项目(2021ZYY04,2021ZYY15);浙江省新一轮卫生商层次人才培养工程(2021年度医培新秀)。

摘　　要：目的建立HPLC测定人血浆中吡仑帕奈浓度的方法并考察其临床应用。方法采用Agilent ZORBAX SB-C_(18)(4.6 mm×150 mm,5μm)色谱柱,流动相为0.05%磷酸(pH 3.5)-乙腈(56∶44),流速为1 mL·min^(-1),柱温为30℃,检测波长为290 nm。测定癫痫患儿的吡仑帕奈浓度并考察影响血药浓度的风险因素。结果吡仑帕奈在75~2500μg·L^(-1)内线性良好,定量限为75μg·L^(-1),准确度不超过标示值的±10%,精密度的变异系数均≤5%,回收率为97.6%~101.0%,在实验涉及的各种条件下稳定性良好。利用该方法测定了51例癫痫患儿的吡仑帕奈血浆谷浓度,所得浓度结果为91.6~1681.9μg·L^(-1);年龄影响吡仑帕奈浓度,<5岁患者的吡仑帕奈谷浓度显著低于5~12岁患者,但与≥12岁患者无显著差异。结论该方法操作简便,具有较高的准确性和灵敏度,能满足吡仑帕奈治疗药物监测的分析要求,年龄对吡仑帕奈的谷浓度存在显著影响。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-C_(18)(4.6 mm×150 mm,5μm)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 75−2500μg·L^(-1),and the limit of quantitation was 75μg·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 91.6−1681.9μg·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.

关 键 词：吡仑帕奈 高效液相色谱法 血药浓度 临床应用 

分 类 号：R917.101[医药卫生—药物分析学]