目的:用反相高效液相色谱法同时测定人血清中抗癫痫药拉莫三嗪和卡马西平的浓度。方法:以氟西泮作内标,乙腈-磷酸钾缓冲液(0.0mol·L^-1,pH4.5)为流动相,经Symmetry C18(150mm×3.9mm,5μm)色谱柱梯度洗脱、分离.流速为1.0mL·min,波长为305nm的紫外检测器检测。结果:拉莫三嗪和卡马西平的血药浓度分别在0.31—40.00μg·mL^-1(r=0.9999)和0.16—20.00μg·mL^-1(r=0.9996)范围内线性良好;平均回收率分别为98.69%和98.14%;日内RSD(n=5)分别为1.6%-5.8%和1.5%-2.8%,日间RSD(n=5)分别为3.4%~6.5%和5.0%-5.7%;血清中最低检测浓度分别为0.05μg·mL^-1和0.02μg·mL^-1。结论:本方法操作简单,回收率高,精密度好,适用于临床上常规监测拉莫三嗪和卡马西平的血药浓度。
Objective: To establish A rapid, sensitive and simple HPLC method for simultaneous determination of lamotrigine(LTG) and earbamazepine(CBZ) in human serum. Method:The drugs was extracted from 100 μL of serum with dichloromethane - isopropanol (95 : 5 ). The extract was evaporated and the residue was reconstituted with methanol and injected onto the HPLC system. The drugs and the internal standard(flurazepam,FZP) were eluted from a Symmetry C18( 150 mm ×3.9 mm,5 μm) stainless steel column in gradient at 37 ℃ with a mobile phase consisting of acetonitrile -potassium phosphate(0. 01 mol · L^-1 ,pH 4. 5 ), at a flow rate of 1.0 mL ·min^-l and the detector was monitored at 305 nm. Result: Quantitation was achieved by measurement of the peak - area ratio of the drugs to the internal standard , the regression equation of lamotfigine and carbamazepine was A = 0. 465C + 0. 0107(r =0. 9999) and A =0. 704C -0. 0063(r =0. 9996) ,concentrations ranged from 0. 31 μg · mL^-1 to 40. 0 μg · mL^-1 and from 0. 16 μg · mL^-1 to 20. 0 μg · mL^-1 ,and the lowest limit of detection was 0. 05 μg · mL^-1 and 0. 02 μg · mL^-1 respectively. The intra- day RSD of lamotfigine and carbamazepine were 1.6% -5.8% and 1.5% -2. 8% and the inter -day RSD were 3. 4% -6. 5% and 5.0% -5.7% respectively. The relative recoveries of lamotfigine and earbamazepine were 98.69% and 98. 14% respectively. Conclusion: This reliable micro - method would be valuable in monitoring serum level of lamotrigine and carbamazepine in clinic, especially in pediatric patients.