HPLC法测定人血浆中伪麻黄碱浓度方法的改进

目的:建立以改进的高效液相色谱法测定人血浆中伪麻黄碱浓度的方法。方法:人血浆标本以盐酸苯丙醇胺为内标,经碱化和正己烷-二氯甲烷-异丙醇(10∶5∶0.5)提取后,再以0.5%盐酸萃取,取下层有机相进样分析,其中色谱柱为Diamosil C18,流动相为0.2%磷酸-乙腈=9∶1,流速为1mL·min-1,柱温为30℃,检测波长为205nm。结果:伪麻黄碱血浆浓度在3~1 000μg·L-1范围内线性关系良好(r=0.999 1),最低检测限为1μg·L-1;4种浓度的日内RSD均<7%,日间RSD均<8%;平均萃取回收率为81.9%。结论:本方法简便、快速、准确,可用于人体内伪麻黄碱的血药浓度监测及药动学研究。

An Improved HPLC Method for the Determination of Pseudoephedrine in Human Plasma

OBJECTIVE： To determine the concentration of pseudoephedrine （PSE） in human plasma by an improved HPLC method. METHODS： With Phenylpropanolamine HCI as internal standard, human plasma samples were alkalified and extracted with n- hexane- dichloromethane- isopropyl alcohol （10 ： 5 ： 0.5）, then extracted with 0.5% HCI. The underlayer organic phase was analyzed on Diamosil C18 with mobile phase consisted of 0.2% phosphoric acid - acetonitrile （9 ： 1） at a flow - rate of 1 mL · min^ -1. The column temperature was set at 30 12 and the detection wavelength was set at 205 nm. RE- SULTS： The concentration of PSE was 3--1 000μg · L^-1（r = 0.999 1） with the lowest detectable limit at 1μg · L^-1. At 4 concentrations, the intraday RSD were all less than 7% and the interday RSD of PSE were all less than 8%. The mean recovery rate for PSE was 81.9%. CONCLUSIONS： The method is simple, rapid, accurate, and suitable for pharmacokinetic study and monitoring of serum concentration of PSE.