摘要
目的：建立人血清美他多辛浓度的HPLC测定法，进行美他多辛健康志愿者药代动力学研究。方法：志愿者含药血清经去蛋白处理后，以甲醇-5mmol·L^-1乙酸铵（14：86）为流动相，采用Diamonsil C18柱（250mm×4．6mm，5μm）分离，流速1．0ml·min^-1，检测波长286mm。结果：本法线性范围0．2～12μg·ml^-1，最低定量限0．2μg·ml^-1。血清中关他多辛绝对回收率73．31％～82．00％，方法回收率91．08％～95．69％，日内RSD≤6．3％，日间RSD≤4．3％。结论：本法简单、快速、灵敏、重现性好，是一种有效的检测人血清关他多辛浓度的方法，适用于人体美他多辛药代动力学研究。
AIM： To establish an HPLC method for detennination of metadoxine in human serum and to study the pharmacokinetics of metadoxine in healthy Chinese volunteers.METHODS： The volunteer serum samples were deproteinized and separated on a Diamonsil C18 column （250 mm× 4.6mm, 5μm） , eluted with the mobile phase of methanol -5 mmol·L^-1 ammonium acetate （14：86, v/v） at a flow rate of 1.0 ml·min^-1 and detected at 286 nm.RESULTS： The linear range of the calibration curve for metadoxine was 0.2-12μg·ml^-1,and the low limit of quantitation （LLOQ） was 0.2 μg·ml^-1. The absolute and relative recoveries were 73.31%-82.00% and 91.08%-95.69% respectively. Within-day RSD and between-day RSD were less than 6.3 % and 4.3 %. CONCLUSION： The assay method is simple, sensitive, accurate, and reproducible and was successfully applied for the phannacokinetic study of metadoxine in healthy volunteers.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2006年第4期440-443,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
