HPLC法测定癫痫患儿血浆中拉莫三嗪的浓度

目的:建立以高效液相色谱法测定癫痫患儿血浆中拉莫三嗪浓度的方法。方法:采用外标法,以甲醇沉淀法处理血样后进样测定,色谱柱为Intersil ODS-3,流动相为甲醇-0.1%磷酸溶液(30∶70),流速为1.0mL·min-1,检测波长为225nm,柱温为27℃。结果:拉莫三嗪血药浓度在0.8～40μg·mL-1范围内线性关系良好(r=0.9999),定量下限为0.5μg·mL-1;平均回收率为(99.35±3.93)%,日内、日间RSD均<5%。20例癫痫患儿拉莫三嗪血药浓度的范围为1.3～15.4μg·mL-1,中位数为4.7μg·mL-1。患儿血浆中拉莫三嗪的血药浓度随年龄的减小,波动范围明显增大。结论:该方法灵敏、准确、简便、快速,适用于拉莫三嗪的血药浓度监测及其药动学研究。年龄越小的患儿,越需要对拉莫三嗪进行血药浓度监测。

Plasma Concentration of Lamotrigine in Children with Epilepsy by HPLC

OBJECTIVE ： To determine the concentration of lamotrigine in plasma of children with epilepsy by HPLC. METHODS： The plasma sample after precipitation with methanol was determined by RP-HPLC. The chromatographic column was Intersil ODS-3（250 mm×4.6 mm, 5 μm）column with mobile phase consisted of methanol-0.1% phosphoric acid solution （30：70）. The detection wavelength was 225 nm and the flow rate was 1.0 mL.min 1. The column temperature was kept at 27 ℃. RESULTS： The linear range of lamotrigine was 0.8-40 μg·mL^-1（r=- 0.999 9）, and the detection limit was 0.5μg·mL^-1. The average recovery was （99.35 ± 3.93）%. The RSD of intra-day and inter-day were less than 5%. The concentration range of lamotrigine in 20 epileptic children was 1.3- 15.4μg·mL^-1 with median concentration of 4.7 μg·mL^-1. The concentration range of lamotrigine increased as the age of children decreased. CONCLUSION： The method is sensitive, accurate, easy, rapid and suitable for the plasma concentration monitoring and pharmacokinetic study of lamotrigine. The younger the child is, the more need therapeutic drug monitoring requires.