高广慧,王晓黎,董宇,战祥友,慕善学
GAO Guang-hui1,WANG Xiao-li1,DONG Yu1,ZHAN Xiang-you1,MU Shan-xue2(1.Liaoning Provincial Institute of Food and Drug of Control

• 1:辽宁省食品药品检验所
• 2:辽宁省食品药品检验所
• 3:辽宁省食品药品检验所
• 4:辽宁省食品药品检验所

摘要(Abstract)：

目的建立同一色谱条件测定复方氨酚苯海拉明片中的对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明含量的HPLC法。方法采用苯基柱(4.6 mm×250 mm,5μm),流动相为甲醇-pH 3.5的10 mmol.L-1乙酸铵溶液(体积比85∶15),检测波长为225 nm。结果对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明的分离度好,对乙酰氨基酚、咖啡因、盐酸麻黄碱和盐酸苯海拉明的回收率分别为100.1%、100.0%、100.2%和100.6%(n=9)。结论本方法操作简单,结果准确,可以有效地控制复方氨酚苯海拉明片的质量。
Objective To establish a method for determining the compound paracetamol and diphenhydramine hydrochloride tablets by HPLC.Methods Phenyl column was used and methanol-10 mmol·L-1 pH3.5 ammonium acetate buffer(V∶V=85∶15) was selected as mobile phase;the wavelength of detector was set at 225 nm.Results Paracetamol,caffeine,ephedrine hydrochloride and diphenhydramine hydrochloride were well separated.The average recoveries were 100.1%,100.0%,100.2% and 100.6%(n=9),respectively.Conclusions This method is simple,accurate and convenient.It is very suitable for the quality control of the compound paracetamol and diphenhydramine hydrochloride tablets.

关键词(KeyWords)： 高效液相色谱法;复方氨酚苯海拉明片;对乙酰氨基酚;咖啡因;盐酸麻黄碱;盐酸苯海拉明
HPLC;compound paracetamol and diphenhydramine hydrochloride tablets;paracetamol;caffeine;ephedrine hydrochloride;diphenhydramine hydrochloride

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 高广慧,王晓黎,董宇,战祥友,慕善学
GAO Guang-hui1,WANG Xiao-li1,DONG Yu1,ZHAN Xiang-you1,MU Shan-xue2(1.Liaoning Provincial Institute of Food and Drug of Control

参考文献(References)：

• [1]国家药典委员会.WS-10001-(HD-1152)-2.国家药品标准12册:复方氨酚苯海拉明片化学药品地标上升国家标[S].北京:出版者不详,2002:162.
• [2]郭瑞锋,郄冰冰.复方氨酚苯海拉明片中对乙酰氨基酚和咖啡因的含量测定[J].中国药业,2006,15(16):24-25.
• [3]修荣,朱梅英.抗感冒药麦克中对乙酰氨基酚和咖啡因的含量测定[J].理化检验:化学分册,2006,42(1):54-54,56.
• [4]程辉跃.HPLC法同时测定百喘朋中盐酸麻黄碱和盐酸苯海拉明的含量[J].中国药房,2001,12(10):622-623.