HPLC法测定复方苯海拉明麻黄碱糖浆中麻黄碱、苯海拉明的含量

目的:研究并建立同时测定复方苯海拉明麻黄碱糖浆中盐酸麻黄碱、盐酸苯海拉明含量的HPLC法.方法:采用Sino Chmm ODS-BP C18(200 mm×4.6 mm,5μm)色谱柱,流动相为0.02 mo儿十二烷基硫酸钠溶液-乙腈-三乙胺(48:52:0.1),用磷酸调节pH至(3.50±0.05),流速为0.8 ml/min,检测波长为257 nm,柱温为35℃.结果:盐酸麻黄碱、盐酸苯海拉明的线性范围分别为0.585 6～5.856 0μg(r=0.999 9)和0.508 4-5.084 0 μg(r=0.999 9),平均回收率分别为98.3%(RSD=1.01%)和98.5%(RSD=1.12%).结论:该法快速、简便、准确,可用于复方苯海拉明麻黄碱糖浆的质量控制.

Content determination of ephedrine hydrochloride and diphenhydramine hydrochloride in Compound Diphenhydramine Hydroehloride and Ephedrine Hydrochloride Syrup by HPLC

Objective: To establish a method for determining the contents of ephedrine hydrochloride and diphenhy-dramine hydrochlofide in Compound Diphenhydramine Hydrochloride and Ephedrine Hydrochloride Syrup simultaneously. Methods: RP-HPLC was used with a Sino Chrom ODS-BP C18 column (200 min×4.6 mm, 5 μm), the mobile phase was a mixture of 0.02 mol/L sodium laurylsulfate solution-seetonitrile-triethanolamine (48:52:0.1), the flow rate was 0.8 ml/min and the detection wavelength was 257 nm, the column temperature was 30%. Results: The linear range was within 0.585 6-5.856 0 μg(r=-0.999 9), the average recovery was 98.3%(RSD=1.01%) for ephedrine hydrochloride; and the linear range was within 0.508 4-5.084 0 μg (r=-0.999 9), the average recovery was 98.5%(RSD=1.12%) for diphenhydramine hydrochloride. Conclusion: The method is fast, simple and accurate, it can be used for the quality control of Compound Diphenhydramine Hydrochloride and Ephedrine Hydrochloride Syrup.