高效液相色谱法监测癫痫患儿血清中左乙拉西坦的血药浓度

Determination of Levetiracetam in Serum of Children with Epilepsy by HPLC

目的建立测定抗癫痫药左乙拉西坦血药浓度的高效液相色谱（HPLC）法。方法根据液-液萃取法,利用乙酸乙酯从血清中提取出左乙拉西坦,于40℃恒温水浴中经氮气恒流吹干富集浓缩,再用甲醇复溶后进样25μL;流动相为磷酸盐缓冲液（p H=4.0）-乙腈（93∶7,V/V）,流速1.0 m L/min,柱温为40℃,色谱柱采用岛津RP-C18柱（150 mm×3.9 mm,5μm）,检测波长为210 nm。结果左乙拉西坦线性回归方程为Y=46 853 X＋23 250,r=0.999 8（n=5）,质量浓度在5.120-51.20μg/m L范围内与峰面积线性关系良好。结论该方法验证符合血清样品的测定要求,可用于临床血药浓度测定及药代动力学研究。

Objective To establish an HPLC method for the serum concentration of antiepileptic drug levetiracetam.M ethods Levirairacetam was extracted from serum by ethyl acetate using liquid-liquid extraction method,and was concentrated in a constant temperature water bath at 40℃ by constant nitrogen drying.After reconstituted with methanol,25μL was injected.The RP-C_（18） column（Shimadzu150 mm×3.9 mm,5 μm） was used;the mobile phase was phosphate buffer（pH=4.0）-acetonitrile（93：7,V/ V）,the detection wavelength was set at 210 nm,at a flow rate of 1.0 mL/min and the column temperature was 40℃.The chromatographic peak of levetiracetam was recorded,and the linear regression equation was made according to the peak area and fitted concentration.Results The linear regression equation was Y=46 853X＋23 250（r=0.999 8）.The linear range was 5.120-51.20μxg/mL.Conclusion The method is proved to be suitable for the determination of serum samples,which can be used for the serum concentration in the clinic and in the pharmacokinetics study.