HPLC法测定人血浆中盐酸伪麻黄碱浓度

HPLC Determination of Pseudo-ephedrine Hydrochloride Concentration in Human Plasma

建立反相高效液相色谱法检测人血浆中盐酸伪麻黄碱浓度的方法。首次应用了盐酸雷诺嗪为内标，血样处理采用乙醚两次提取，再用0．1mol·L^-1硫酸溶液反提萃取，萃取液直接进行高效液相色谱分析。色谱柱为AgilentZorbaxSB—C18，12．5mm C18预柱，流动相为乙腈-水（30mmol·L^-1 SDS，30mmol·L^-1 NaH2PO4，0．3％三乙胺）（50：50），流速1．0mL·min^-1，柱温：25℃，紫外检测波长为210nm。盐酸伪麻黄碱与内标和杂质峰分离良好，最低检测浓度为10ng·mL^-1。线性范围为19．06～1220ng·mL^-1。日间、日内精密度平均值为7．54％，平均萃取回收率为95．5％，方法回收率为96．44％。本法可作为盐酸伪麻黄碱血药浓度的测定方法，用于临床血药浓度的测定及药代动力学的研究。

A HPLC method to determine Pseudo -ephedrine hydrochloride （PSE） in human plasma was established. The human plasma was extracted with ether twice, and then extracted with 0. 1M solution of sulfuric acid. Ranolazine was used as the internal standard. The sample was separated and determined with a Agilent Zorbax SB - C18 column with acetonitrile and a buffer solution （30mmol · L^-1SDS, 30mmol · L^-1 sodium dihydrogen phosphate, 0. 3%triethylamine ） （50： 50） as the mobile phase at the flow rate of lmL · min^-1. The detection wavelength was at 210nm. A good linearity over the range of 19. 0625 - 1220ng · mL^-1 was achieved. All the RSD of intra - day and inter - day were less than 9.74%, and the recovery was more than 93.58%. This method is simple, sensitivity, accurate, and high precision, and could be used for the studies of PSE pharmacokinetics in human.