HPLC-MS/MS法检测儿童患者血浆中的西替利嗪浓度  

Determination of cetirizine in the plasma of children by HPLC-MS/MS

作　　者：杨平 周薇[2] 张现化[1,3] 周从亚 杨丽 刘维[1,3] YANG Ping;ZHOU Wei;ZHANG Xian-hua;ZHOU Cong-ya;YANG Li;LIU Wei(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Pediatrics,Peking University Third Hospital,Beijing 100191,China;Therapeutic Drug Monitoring and Clinical Toxicology Center of Peking University,Beijing 100191,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京大学第三医院儿科,北京100191 [3]北京大学治疗药物监测和临床毒理中心,北京100191

出　　处：《中国临床药理学杂志》2021年第22期3161-3164,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家科技重大专项基金资助项目(2017ZX09304029-005-02)。

摘　　要：目的建立测定儿童血浆中西替利嗪浓度的高效液相色谱-质谱(HPLC-MS/MS)分析法。方法含有西替利嗪的血浆样本采用80%乙腈沉淀蛋白,以西替利嗪-d4为内标。使用亲水HILIC silica色谱柱(5μm,2.1 mm×150 mm)分离,流动相为乙腈(含0.1%甲酸)-5 mmol·L^(-1)甲酸铵水溶液(含0.1%甲酸),梯度洗脱,柱温40℃,流速为0.3 mL·min^(-1),电喷雾离子源,多反应监测模式。西替利嗪监测的离子对m/z 389.3→m/z 201.0,内标监测离子对m/z 393.5→m/z 201.0。结果西替利嗪在0.5~500 ng·mL^(-1)线性关系良好,相关系数>0.998,批内、批间准确度分别为90.8%~101.5%和92.4%~103.8%,批内、批间的精密度在12.8%和13.5%以内。用本方法对12例临床患儿的血浆浓度进行了检测分析。结论所建立的方法可用于快速检测儿童血浆中的西替利嗪浓度,为该群体的药代动力学研究提供数据支持。Objective To establish a HPLC-MS/MS method for the determination of cetirizine in the plasma of children.Methods Plasma samples containing cetirizine were precipitated with 80%acetonitrile and cetirizine-d4 as internal standard(IS).Chromatographic separation was performed on a HILIC silica column(5μm,2.1 mm×150 mm)with a gradient mobile phase of ammonium formate(5 mmol·L^(-1),containing 0.1%formic acid)-acetonitrile(containing 0.1%formic acid).The column temperature was set to 40℃,The flow rate of mobile phase was 0.3 mL·min^(-1).Detection was performed in positive mode with an ESI source.The MRM transitions were m/z 389.3→m/z 201.0 and m/z 393.5→m/z 201.0 for cetirizine and the IS,respectively.Results The linear range was 0.5-500 ng·mL^(-1)(r>0.998).The intra-and inter-batch accuracy was 90.8%-101.5%and 92.4%-103.8%,intra-and inter-batch RSDs were lower than 12.8%and 13.5%,respectively.The method was applied to the detection of cetirizine concentration in the plasma of 12 children.Conclusion The established method is suitable for the rapid detection of cetirizine concentration in the plasma of children and provide data support for pharmacokinetic study of this population.

关 键 词：西替利嗪 液相色谱-质谱 儿童 药代动力学 

分 类 号：R97[医药卫生—药品]