高效液相色谱法测定复方氨酚苯海拉明片中盐酸麻黄碱和盐酸苯海拉明的含量及均匀度

HPLC determination of content and content uniformity of ephedrine hydrochloride and diphenhydramine hydrochloride in Fufang Anfen Benhailaming tablets

目的：建立高效液相色谱法测定复方氨酚苯海拉明片中盐酸麻黄碱和盐酸苯海拉明的含量及均匀度。方法：采用Diamonsil^TM C18柱（4．6mm×250mm．5μm），以[甲醇水-冰醋酸-四氢呋喃-十二烷基硫酸钠（25：35．0．5：2：0．35g）]乙腈（68：32）为流动相；检测波长为257nm。结果：盐酸麻黄碱平均回收率为99．1％，RSD为0．7％（n=5），线性范围为1．578～12．624μg；盐酸苯海拉明平均回收率为99．0％，RSD为0．7％（n=5），线性范围为1．53～12．24μg。结论：该方法重复性好．结果准确，可用于该制剂的质量控制。

OBJECTIVE To establish the determination method of ephedrine hydrochloride and diphenhydramine hydrochloride in Fufang Anfen Benhailaming tablets by HPLC. METHODS The determination was carried out on Diamonsil^TM C18 column with mobile phase of [methanol water acetic acid glacial tetrahydrofuran-sodium laurylsulfate （25：35：0. 5：2：0. 35 g）]- acetonitrile（68：32） and detection wavelength at 257 nm. RESULTS The linear correlation of ephedrine hydrochloride and diphen hydramine hydrochloride were observed over the concentrations 1. 578 to 12. 624μg and 1.53 to 12.24μg respective. The average recoveries of ephedrine hydrochloride and diphenhydramine hydrochloride were 99. 1 % with RSD of 0. 7% （n = 5） and 99. 0% with RSD of 0. 7 % （n = 5） respective. CONCLUSION The method is accurate and highly reproducible, It can be a method for guality control of Fufang Anfen Benhailaming tablets.