【摘要】 目的建立血清中10,11-二氢-10-羟基卡马西平(HO-CBZ)的HPLC测定方法,为临床血药浓度监测和代谢动力学提供分析手段。方法以CLC-ODS柱(150 mm×6.0 mm,5μm)为色谱分析柱,柱温40℃,流动相为甲醇-水(40∶60),流速1 mL.min-1;检测波长210 nm。血清样品加适量苯巴比妥作内标,采用乙醚分2次提取,水浴通N2挥干,残留物用流动相复溶后,取10μL进样分析,以内标法定量。结果HO-CBZ在0.1-10μg.mL-1线性关系好,相关系数r为0.999 8,回归方程S(面积比)=0.561 8C+0.236 9(HO-CBZ浓度),方法的最低检测浓度为20 ng.mL-1。HO-CBZ低、中、高3种浓度的平均相对回收率为99.80%,日内RSD0.61%-3.12%,日间RSD 1.00%-4.17%。结论本方法结果准确,操作简便,成本低,易于质量控制,适合临床HO-CBZ血药浓度监测及药物动力学研究。更多还原

【Abstract】 Objective To establish an HPLC method for the determination of 10,11-dihydro-10-hydroxy-carbamazepine(HO-CBZ) in the serum.Methods HO-CBZ was analyzed on a CLC-ODS column(150 mm×6.0 mm ID,5 μm) at 40 ℃ with the mobile phase of methyl alcohol-water(40∶60),1.0 mL·min-1.The UV wavelength was 210 nm.Serum samples were extracted by ether with luminal as the internal standard.The ether extract was evaporated under nitrogen at 50 ℃.The residue was reconstituted with the mobile phase.Results The calibration curve was linear over 0.1～10 μg·mL-1,with the correlation coefficient of 0.999 8.The detection limit was 20 ng·mL-1,The mean relative recovery of HO-CBZ was 99.80%,the intraRSD was 0.61%～3.12%,and inter-RSDs 1.00%～4.17%.Conclusion The method is accurate,cheap,and easy to operate.It is suitable for the therapeutic drug monitoring of HO-CBZ in clinical and pharmacokinetic research.更多还原