拉莫三嗪血药浓度检测方法构建与干扰因素研究

摘要

目的 构建灵敏、快捷、稳定的拉莫三嗪(LTG)血药浓度高效液相色谱(HPLC)测定法,并对其常见影响因素进行分析.方法 用Agilent Exlipse XDB-C18(4.6×150mm,5μm)色谱柱,柱温25℃;以40mM/L甲酸铵-乙腈-0.25%三乙胺(70:20:10,V/V)为流动相,流速1ml/min;用310nm波长检测LTG,250nm波长检测内标(非那西丁);比较同血样中血浆和全血LTG浓度的差异性;将其他常见抗癫痫药物加入待测LTG血样中观察是否对LTG测定产生干扰.结果 LTG在0.1~50μg/ml范围内线性良好(r>0.999),定量下限为0.1μg/ml,提取回收率为75.67%~83.12%,日内日间精密度、进样瓶内、冷藏及冻融稳定性RSD均0.999)for LTG. The lowest limit of quantification was 0.1μg/ml. The recoveries of this method were 75.67%~83.12% for LTG.The intra-day and inter-day precision values (RSD) was less than 10%.After being stored in sample bottle,frozen and freeze-thaw it stability RSD were less than 10%. There were no significant difference of LTG concentrations in blood plasma and whole blood for the same sample(two tails t=3.880,P=0.001). Conclusion LTG plasma drug concentration determination by high performance liquid chromatography has good stability, high sensitivity, and is not interfered by other common anti-epileptic drugs. It can be used for clinical drug concentration detection. Whole blood can be used instead of plasma to determine LTG concentration when blood sample is less or hemolysis occurs.