HPLC法测定盐酸伪麻黄碱血药浓度

Determination of plasma pseudoephedrine hydrochloride concentrations by HPLC

目的:建立盐酸伪麻黄碱血药浓度高效液相色谱法测定方法。方法:采用液-液萃取法,以对硝基苯胺为内标,测定盐酸伪麻黄碱血药浓度。在5例志愿受试者服药后测定了盐酸伪麻黄碱血药浓度,药代动力学参数用3P97程序计算。结果:盐酸伪麻黄碱在20～4000ng/ml范围内线性良好,得回归方程:Y=1180.1630X+5.5970,r=0.9984,最低检出限20ng/ml,绝对回收率(91.61±8.07)%;内标总回收率(90.92±5.14)%,平均日内日间差5.98%。结论:测定方法灵敏、结果准确,可为临床血药浓度检测和药代动力学研究使用。

Objective：To establish an HPLC method for the determination of pseudoephedrine hydrochloride concentrations in blood plasma.Methods：The liquid-liquid extraction was also used for the process of the samples from five volunteers after oral administration of pseudoephedrine dispersible tablets.Para-nitroaniline was applied as an internal standard.Pharmacokinetic parameters were calculated by 3P97.Results：The standard curve of pseudoephedrine hydrochloride was liner within the rang of 20～4 000 ng/ml,and regression equation was Y=1 180.163 0 X＋5.597 0 with r=0.998 4.LOQ was 20 ng/ml,and absolute recoveries of pseudoephedrine hydrochloride and internal standard were 91.61%±8.07% and 90.92%±5.14% respectively.The average of intra-day and inter-day variations was 5.98%.Conclusion：A simple and sensitive HPLC method was developed for the determination of pseudoephedrine hydrochloride in human plasma.