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目的建立RP-HPLC法同时测定人血浆中奥卡西平含量及活性代谢物利卡西平(10,11-二氢-10-羟基卡马西平)浓度,为临床癫痫患者个体化治疗方案的实施提供指导。方法血清样品经乙醚提取后Agilent ZORBAX SB-C18色谱柱(150mm×4.6mm,5μm)进样分析,流动相:甲醇-水(40∶60);流速:1.0ml·min-1;检测波长:220nm;柱温:30℃;以苯巴比妥为内标。结果在一定范围内(利卡西平0.56~55.5μg·ml~(-1),r=0.9996;奥卡西平0.64~64.2μg·ml~(-1),r=0.9990)各药物与内标峰面积比与浓度呈良好的线性关系,最低检测限为0.20μg·ml~(-1)。低、中、高浓度质控品回收率均>90%(n=5),日内、日间变异均<10%(n=5)。结论本方法操作简单、成本低、精密度及回收率均满足生物样本分析要求,结果稳定可靠,适合在基层医院开展。
OBJECTIVE To establish an RP-HPLC method for the simultaneous determination of oxcarbazepine concentration and the active metabolite licaxepine (10,11-dihydro-10-hydroxycarbamazepine) concentration in human plasma for the implementation of individualized treatment regimens for patients with clinical epilepsy guide. Methods The samples were analyzed by Agilent ZORBAX SB-C18 column (150mm × 4.6mm, 5μm) after extraction with diethyl ether. The mobile phase was methanol-water (40:60), the flow rate was 1.0ml · min-1, 220nm; column temperature: 30 ℃; phenobarbital as internal standard. The results showed that within a certain range (0.56 ~ 55.5μg · ml -1, r = 0.9996) and oxaliplatin (0.64 ~ 64.2μg · ml -1, r = 0.9990) The area ratio and concentration showed a good linear relationship with the detection limit of 0.20μg · ml ~ (-1). The recoveries of low, medium and high quality control products were all higher than 90% (n = 5). The intra-day and inter-day variation were all less than 10% (n = 5). Conclusion The method is simple, low cost, precision and recovery rate to meet the biological sample analysis requirements, the results are stable and reliable, suitable for primary hospital.