HPLC法同时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

Content Determination of Ephedrine Hydrochloride and Diphenhydramine Hydrochloride in Compound Anfenbenbenhailaming Tablets by HPLC

目的建立HPLC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。方法用Kromasil C18(250mm×4.6mm,5μm)色谱柱;流动相甲醇—乙腈—1%十二烷基硫酸钠溶液(26∶32∶42)(冰醋酸调pH值3.1),检测波长257nm。结果线性范围,盐酸麻黄碱:1.2288～11.0592μg,r=0.9999盐酸苯海拉明:1.2168～10.9512μg,r=1.0000;平均回收率,盐酸麻黄碱98.79%,RSD%=0.59%盐酸苯海拉明100.44%,RSD%=0.57%。结论本方法简便、准确、灵敏度高、重现性好,可更好地控制本品的质量。

Objective To establish a method for the determination of Ephedrine Hydrochloride and Diphenhydramine Hydrochloride in Compound Anfenbenbenhailaming Tablets by HPLC. Methods The Kromasil C18（250mm × 4.6mm,5 μ m）column;the mobile phase was methanol-acetonitrile-1% sodium laurylsulfate selution（26 ： 32 ： 42）（the pH of mobile phase was adjusted to 4.5 with acetic acid glacial）.The detection wavelength was 257nm.Resuts The linear range： Ephedrine Hydrochloride was 1. 2288 - 11. 0592 μg,r=0.9999, Diphenhydramine Hydrochloride was 1.2168-10.9512 μg,r=1.0000;The recovery rate： Ephedrine Hydrochloride was 98.79%, RSID%=0.59%, Diphenhydramine Hydrochloride was 100.44%,RSD%=0.57% ; Conclusion The method is simple, accurate, highly serious and reproducible,and can provide a reference standard for the quality control of Ankahuangmin capsule.