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目的:建立用高效液相色谱快速检测拉米夫定血药浓度的方法。方法:用10％高氨酸和20％三氯乙酸直接沉淀血清蛋白,三氯甲烷抽提血清杂质成分,离心后取上清液进行色谱分析;色谱柱为Shim-Pack VP-ODS柱,流动相为0.02mol·L~(-1)磷酸盐缓冲液(pH7.0)-乙腈-甲醇(91:0.1:9),流速为1.5mL·min~(-1),紫外检测波长274nm,喷昔洛韦为内标。结果:拉米夫定的保留时间为7.9min,定量线性范围0.050～4.0mg·L~(-1)(r=0.9998),方法回收率大于94.60％(n=5)。日内RSD<4%,日间RSD<7%,n=5。结论:本法简便快速、定量准确,适用于拉米夫定人体临床药代动力学和生物利用度的研究。
Objective: To establish a rapid method for the determination of lamivudine concentration by high performance liquid chromatography. Methods: Serum protein was directly precipitated with 10% of HA and 20% of trichloroacetic acid. The impurities in serum were extracted by chloroform and centrifuged. The supernatant was chromatographed. The column was Shim-Pack VP-ODS Phase was 0.02mol·L -1 phosphate buffer (pH7.0) -acetonitrile-methanol (91: 0.1: 9), the flow rate was 1.5mL · min -1, UV detection wavelength was 274nm, Cyclocarb is an internal standard. Results: The retention time of lamivudine was 7.9 min. The linear range was 0.050 ~ 4.0 mg · L -1 (r = 0.9998). The recovery rate of lamivudine was more than 94.60% (n = 5). Days RSD <4%, daytime RSD <7%, n = 5. Conclusion: The method is simple, rapid and accurate. It is suitable for the study of human clinical pharmacokinetics and bioavailability of lamivudine.