LC-MS/MS法测定人血浆中阿美替尼的浓度  

Determination of almonertinib in human plasma by liquid chromatography-tandem mass spectrometry

作　　者：李颖[1] 支旭然[1] 邢晓清 安静[1] 郭彩会[1] 白万军[1] 董占军[1] LI Ying;ZHI Xu-ran;XING Xiao-qing;AN Jing;GUO Cai-hui;BAI Wang-jun;DONG Zhan-jun(Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050051,Hebei Province,China)

机构地区：[1]河北省人民医院药学部,河北石家庄050051

出　　处：《中国临床药理学杂志》2022年第13期1531-1534,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 建立一种测定人血浆中阿美替尼浓度的液质联用法。方法 以d3-索拉非尼为内标,血浆样品经乙腈沉淀蛋白,用XSelect HSS XP (2.1 mm×100.0 mm, 2.5μm)色谱柱进行分离,流动相为2 mmol·L^(-1)乙酸铵(含0.1%甲酸)-乙腈(含0.1%甲酸)溶液,梯度洗脱,流速为0.5 mL·min^(-1),采用电喷雾离子源(ESI)、正离子、多反应监测模式。结果 血浆中内源性物质不干扰测定,阿美替尼在2~500 ng·mL^(-1)线性关系良好,定量下限为2 ng·mL^(-1),日内、日间精密度RSD均小于15%,准确度在95.8%~105.2%,内标归一化的基质效应因子为96.3%~100.8%。结论 本方法高效、准确、快速,可用于阿美替尼血浆药物浓度测定及药代动力学研究。Objective To establish a rapid, specific, accurate liquid chromatography-tandem mass spectrometry(LC-MS/MS) method for the determination of almonertinib concentration in human plasma. Methods d-sorafenib was used as the internal standard. The plasma samples were extracted by protein precipitation with acetonitrile(LLE) and separated on XSelect HSS XP column(2.1 mm × 100.0 mm, 2.5 μm) with acetonitrile(0.1% formic acid) and 2 mmol·Lammonium acetate(0.1% formic acid) at the flow rate of 0.5 mL·min^(-1). Electrospray ion source(ESI), positive ion, and multi-response monitoring modes were used. Results Chromatograms showed no endogenous interfering with blank samples. Almonertinib showed a good linear relationship in the range of 2-500 ng·mL^(-1). The lower limit of quantification was 2 ng·mL^(-1). The accuracy of both intra-day and inter-day studies were ranged from 95.8%-105.2%, and the RSD was less than 15%. The internal standard normalized matrix effect was 96.3%-100.8%. Conclusion This method is rapid, simple, accurate and suitable for the determination of almonertinib plasma concentration monitoring in humans.

关 键 词：阿美替尼 液相色谱-串联质谱法 血药浓度 

分 类 号：R97[医药卫生—药品]