目的 建立人血漿中奧卡西平藥物濃度的RP-HPLC檢測(cè)方法，并研究其在人體內(nèi)的藥動(dòng)學(xué)。方法 采用液–液萃取法，用萃取液甲基叔丁基醚萃取癲癇患者血漿中的奧卡西平后，以阿普唑侖為內(nèi)標(biāo)。色譜柱為Kromasil 100A C18（250 mm×4.6 mm，5 μm），柱溫40 ℃，流動(dòng)相為甲醇–乙腈–水–磷酸（30∶30∶40∶0.04），體積流量1.0 mL/min，紫外檢測(cè)波長(zhǎng)243 nm，固定進(jìn)樣量20 μL。以3p97軟件計(jì)算10名受試者清晨空腹單劑量口服奧卡西平片600 mg后的平均藥動(dòng)學(xué)參數(shù)。結(jié)果 血漿中內(nèi)源性雜質(zhì)對(duì)樣品測(cè)定無(wú)干擾，奧卡西平在21.6～2 160.0 μg/L（r=0.999 2）線(xiàn)性關(guān)系良好，最低定量限21.6 μg/L；方法回收率為95.45%～107.69%；日內(nèi)RSD值為4.97%～7.35%，日間RSD值為4.81%～11.27%。含藥血漿經(jīng)3次凍融后穩(wěn)定性良好。結(jié)論 本方法操作快速、簡(jiǎn)便、靈敏度高、準(zhǔn)確度好，可用于含奧卡西平血樣的即時(shí)檢測(cè)分析和臨床藥動(dòng)學(xué)研究。

Objective To establish an RP-HPLC method for the determination of oxcarbazepine in plasma of epileptic patient and to study its pharmacokinetics. Methods Acidified plasma samples were processed by a simple liquid-liquid extraction. Alprazolam was used as internal standard. The HPLC analytical column was Kromasil 100A C18 (250 mm × 4.6 mm, 5 μm) at 40 ℃, the mobile phase consisted of a mixture of CH3OH-CH3CN-H2O-H3PO4 (30∶30∶40∶0.04), and delivered at a flow of 1.0 mL/min. The UV detection wavelength was set at 243 nm, and the injection volume was 20 μL. The pharmacokinetic parameters of oxcarbazepine in 10 volunteer after a single oral dose of Oxcarbazepine Tablets (600 mg) were calculated using 3p97 Software. Results The drug from plasma did not interfere with the determination of oxcarbazepine and alprazolam. The concentration of oxcarbazepine in plasma had good linearity relationship (r = 0.999 2) in the range of 21.6 —2 160.0 μg/L. The lowest detection limit was 21.6 μg/L. The recovery ranges were 95.45% — 107.69%. The RSD values of intra- and inter-day were 4.97% — 7.35% and 4.81% — 11.27%, respectively. The sample stability was good after freeze thaw for three times. Conclusion The method is simple, sensitive, and accurate. This could be used for the immediate analysis of the concentration of oxcarbazepine in plasma and pharmacokinetics study.