中国临床药理学杂志2026，Vol.42Issue(2)：231-236,6.DOI:10.13699/j.cnki.1001-6821.2026.02.013
用微量检测联合HPLC-MS/MS法测定癫痫儿童血浆中唑尼沙胺浓度
Determination of zonisamide in epilepsy children by micro-detection technology combined with HPLC-MS/MS
摘要
Abstract
Objective To establish a method for determination of zonisamide in plasma of epileptic children by micro-detection technology combined with high performance liquid chromatography-mass spectrometry(HPLC-MS/MS).Methods 10 μL of plasma samples were pre-treated by precipitation protein method with organic solvent.Reversed-phase chromatographic columns were adopted.Flow phase:0.075％formic acid-2 mmol·L-1 ammonium acetate-water(A)and methanol(B),gradient elution;flow speed:0.45 mL·min-1;injection volume:1 μL.The quantitative method adopted the internal standard method,and the isotope internal standard was zonisamide-15N-D4.Ion source was electric spray ion(ESI)source,multireaction monitoring(MRM)mode for quantitative analysis,using positive ion monitoring mode.The specificity,standard curve,lower limit of quantitation(LLOQ),residual effect,precision,matrix effects,extraction recovery and stability were investigated.Results The retention times of zonisamide and its internal standard were both 1.25 min,and there was no interference from endogenous substances within the retention time.The linear range of zonisamide was 1-62.5 μg·mL-1(r=0.999 7),and LLOQ was 1 μg·mL-1.The intra-day and inter-day precision RSD was equal or less than 4.84％,and the accuracy ranges from 97.75％-107.95％,with good stability,and this method was not affected by common matrix.Conclusion This method involves micro-blood collection,which is simple to operate,highly efficient and rapid,and can be used for the monitoring of daily therapeutic drugs in children with epilepsy in clinical practice.关键词
唑尼沙胺/液相色谱-质谱联用法/微量检测技术/治疗药物监测/儿童Key words
zonisamide/HPLC-MS/MS/micro-detection technology/therapeutic drug monitoring/children分类
医药卫生引用本文复制引用
马英华,秦亚彬,白冰,张硕,赵宜乐..用微量检测联合HPLC-MS/MS法测定癫痫儿童血浆中唑尼沙胺浓度[J].中国临床药理学杂志,2026,42(2):231-236,6.基金项目
河北省医学科学研究课题计划资助项目(20250802) （20250802）
