目的建立人血浆中拉米夫定质量浓度的LC-MS/MS测定方法,并应用于拉米夫定片在健康人体内的生物等效性研究及评价。方法前处理方法采用沉淀蛋白法。分离选用Venusil ABS C18色谱柱,以甲醇-水-甲酸(体积比5.0∶95.0∶0.1)为流动相,采用多反应离子监测(multiple reaction monitoring,MRM)模式进行正离子检测。结果拉米夫定的线性范围为0.020 0~5.00 mg·L-1,定量下限为20μg·L-1。方法准确度为95.0%~102.4%,日内和日间精密度均不大于7.6%。结论本方法适用于拉米夫定人体生物等效性试验研究。24名健康受试者口服拉米夫定参比制剂和受试制剂后的药代动力学行为一致。 Objective To establish a LC-MS / MS method for the determination of lamivudine in human plasma and to evaluate the bioequivalence of lamivudine in healthy volunteers. Pretreatment method using precipitation protein method. Venusil ABS C18 column was used for separation, and the mobile phase was methanol-water-formic acid (5.0: 95.0: 0.1). The multiple reaction monitoring (MRM) Results The linear range of lamivudine was 0.020 0-5.00 mg · L -1, and the lower limit of quantitation was 20 μg · L -1. The accuracy of the method was 95.0% ~ 102.4%, and the precision of intra-day and inter-day were not more than 7.6%. Conclusion This method is suitable for lamivudine human bioequivalence test. Twenty-four healthy subjects had the same pharmacokinetic behavior after oral lamivudine reference formulation and test preparation.