高效液相色谱-质谱联用测定人血浆中盐酸曲美他嗪

HPLC-MS determination of trimetazidine dihydrochloride in human plasma

目的:建立高效液相色谱-质谱法测定人血浆中盐酸曲美他嗪浓度的方法。方法:血浆样品加入内标,碱化后用乙酸乙酯提取,进行 LC-MS 测定。色游柱为 Luna C_8,流动相为0.02 mol·L^(-1)乙酸铵(含0.5%三乙胺)-甲醇(50:50),流速为1mL·min^(-1),柱温为30℃;APCI 选择性正离子检测。结果:盐酸曲美他嗪浓度在1～160 ng·mL^(-1)范围内线性关系良好(r=0.9991),最低检测浓度为0.5 ng·mL^(-1),平均提取回收率为64.4%,日内 RSD<15%,日间 RSD<20%。结论:方法简便、快速,灵敏度高,可用于曲美他嗪的药动学研究。

Objective：To establish an HPLC - MS method for the determination of trimetazidine dihydrochloride in human plasma. Methods： After adding clonidine dihydrochloride （ internal standard） and 0. 2 mL of 0.5 mol · L^-1 NaOH solution, the plasma samples were extracted with ethyl acetate and determined by LC - MS. The analytical column was Luna C8, the mobile phase consisted of 0.02 mol · L^-1 ammonium acetate （including 0.5% triethylamine） -methanol（50： 50）with a flow rate of 1.0 mL · min^-1. Results：The calibration curve was linear in the concentrations ranging from 1.0 to 160 ng · mL^-1（r = 0. 9991 ）. The average extraction recovery was 64.4%. The intra-day RSD was less than 15% and inter- day RSD was less than 20%. Conclusion：The method is simple, rapid, accurate and suitable for the determination of trimetazidine dihydrochloride in human plasma and pharmacokinetic study.