中国药业2025，Vol.34Issue(9)：53-57,5.DOI:10.3969/j.issn.1006-4931.2025.09.011
超高效液相色谱串联质谱法同时测定癫痫患儿拉考沙胺和吡仑帕奈血药浓度
Simultaneous Determination of Blood Drug Concentrations of Lacosamide and Perampanel in Children with Epilepsy by UPLC-MS/MS
摘要
Abstract
Objective To establish an ultra-high performance liquid chromatography-mass spectrometry(UPLC-MS/MS)method for simultaneous determination of the blood drug concentrations of lacosamide and perampanel in human serum,and to monitor the blood drug concentrations in children with epilepsy.Methods The chromatographic column was Agilent SB-C18 column(50 mm×2.1 mm,1.8 µm),the mobile phase was acetonitrile(containing 0.1%formic acid)-water(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 40℃,and the injection volume was 1 µL.Lacosamide-D6 was taken as the internal standard of lacosamide,and impurity 5 of perampanel was taken as the internal standard of perampanel.The determination was performed by the electrospray ionization(ESI)source,multiple reactions monitoring(MRM)mode and positive ion mode.Results This method has good specificity and no endogenous interference.The linear ranges of lacosamide and perampanel were 3.125-200 ng/mL(R2>0.998).The recovery rates of low-,medium-,and high-mass concentrations of lacosamide and perampanel were in the range of 91.39%-106.28%.The intraday precision RSD was less than or equal to 7.67%(n=5),and the interday precision RSD was less than or equal to 13.78%(n=5).The method was applied to monitor the blood drug concentration of children with epilepsy taking the drug in the hospital,the results showed that the blood drug concentration of lacosamide in male children was(5.85±4.49)µg/mL,and that in female children was(6.47±3.98)µg/mL,without significant difference(P>0.05).The blood drug concentration of perampanel in male children was(572.52±340.77)ng/mL,which was significantly higher than(819.57±595.71)ng/mL in female children(P<0.05).The blood drug concentration of perampanel in the older age group(12-18 years old)was lower than that in the younger age group(4-11 years old),but there was no significant difference(P=0.20).Conclusion The method is accurate,rapid,highly sensitive,and simple,which can be used for monitoring the blood drug concentrations of lacosamide and perampanel.关键词
超高效液相色谱串联质谱法/拉考沙胺/吡仑帕奈/癫痫患儿/血药浓度监测Key words
UPLC-MS/MS/lacosamide/perampanel/children with epilepsy/therapeutic drug monitoring分类
药学引用本文复制引用
林志燕,杨宇,苏妤萱,黄晓会..超高效液相色谱串联质谱法同时测定癫痫患儿拉考沙胺和吡仑帕奈血药浓度[J].中国药业,2025,34(9):53-57,5.基金项目
中国药理学会基金项目[CTDM(XM)-2018-02-002-038]. （XM）
