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目的 :建立反相高效液相测定人血清中来氟米特 (leflunomide ,Lef)活性代谢物A77172 6 浓度的方法。方法 :采用VP ODSC18柱 ,0 .0 1mmol·L- 1醋酸盐缓冲液 ( pH4.6 ) 乙腈 ( 6 7∶3 3 )为流动相 ,紫外检测波长为 2 88nm ,流速 1.0mL·min- 1,血清样品用乙酸乙酯提取。结果 :A77172 6 在血清中得到很好的分离 ,没有明显的干扰峰 ,出峰时间为 6 .4min。线性范围 0 .3 9～ 50mg·L- 1(r =0 .9996 ) ,最低检测限为 0 .0 98mg·L- 1,血清中日内和日间RSD均小于 7% ,回收率为 89.4%～ 95.3 %。结论 :本法简便灵敏 ,符合生物制品分析要求。
Objective: To establish a method for the determination of the concentration of leflunomide (Lef) active metabolite A77172 6 in human serum by reversed-phase high performance liquid chromatography. METHODS: The mobile phase was VP ODSC18 column and acetonitrile (6: 3: 0. 01 mmol·L -1 acetate buffer pH 4.6). The UV detection wavelength was 2 88 nm and the flow rate was 1.0 mL · min- 1, serum samples were extracted with ethyl acetate. Results: A77172 6 was well separated in serum with no obvious interference peak and the peak time was 6.4 minutes. The linear range was from 0.39 to 50 mg · L -1 (r = 0.9996). The lowest limit of detection was 0.098 mg · L -1. The intra-day and inter-day RSD were less than 7% and the recovery was 89.4% ~ 95.3%. Conclusion: This method is simple and sensitive, in line with biological product analysis requirements.