HPLC法测定人血浆中奥卡西平及其活性代谢产物的浓度

Determination of the Concentration of Oxcarbazepine and Its Active Metabolites in Human Plasma by HPLC

目的：建立同时测定人血浆中奥卡西平（OXC）及其活性代谢产物单羟基卡马西平（MHD）浓度的方法。方法：血浆样品采用乙酸乙酯-二氯甲烷（90∶10）处理后,以高效液相色谱法进样测定,其中色谱柱为Agilent C18,流动相为10 mmol/L醋酸铵-甲醇-乙腈（45∶30∶25,V/V/V）,流速为1.0 ml/min,检测波长为225 nm,柱温为30℃,灵敏度为0.01 AUFS。结果：OXC、MHD血药浓度分别在1.0-48.0（r=0.999 6）、3.0-96.0μg/ml（r=0.999 6）范围内线性关系良好,最低检测限为0.5μg/ml;二者低、中、高浓度方法平均回收率分别为97.12%、99.06%、101.27%与96.73%、99.35%、100.86%;提取回收率分别为71.16%、75.38%、77.76%与73.36%、76.52%、77.89%;日内、日间RSD均低于5%（n=5）。结论：该方法灵敏、准确、简便、快速,可用于OXC与MHD临床治疗药物监测（TDM）与药动学研究。

OBJECTIVE：To establish a method for determining the concentration of oxcarbazepine（OXC）and its active metabolite monohydroxycarbazepine（MHD）in human plasma. METHODS：Plasma samples were detected by HPLC after being processed by ethyl acetate and dichloromethane（90：10）. The column was Agilent C18 with the mobile phases of 10mmol/L ammonium acetate-methanol-acetonitrile（45 ∶ 30 ∶ 25,V/V/V）at the flow rate of 1.0 ml/min. The temperature was 30° C,detection wavelength was 225 nm and sensitivity was 0.01 AUFS. RESULTS：There was a good linear relationship in the concentration of OXC and MHD respectively in the range of 1.0-48.0 μg/ml（r=0.999 6）and 3.0-96.0 μg/ml（r=0.999 6）,the lowest limit of detection was0.05 μg/ml. The relative average recoveries of low,middle and high concentration were respectively 97.12%,99.06%,101.27%and 96.73%,99.35%,100.86%;the extraction recoveries were respectively 71.16%,75.38%,77.76% and 73.36%,76.52%,77.89%;the RSD of intra-day and inter-day variation was less than 5%（n=5）. CONCLUSIONS：The method is sensitive,accurate,easy and quick. It can be used for clinical drug monitoring（TDM）and pharmacokinetics studies.