HPLC测定复方氨酚烷胺片中的对乙酰氨基酚、咖啡因和马来酸氯苯那敏  

Determination of paracetamol,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablets by HPLC

作　　者：谢华[1] 傅萍[1] 张悦杨[1] 张蕾[1] 

机构地区：[1]四川省食品药品检验所,四川成都610097

出　　处：《华西药学杂志》2012年第3期307-308,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC同时测定复方氨酚烷氨片中对乙酰氨基酚、咖啡因、马来酸氯苯那敏的含量,增加小剂量成分咖啡因、马来酸氯苯那敏含量均匀度检查的方法。方法采用C18柱,流动相为1%醋酸(二乙胺调pH3.7)-甲醇(62∶38),检测波长对乙酰氨基酚用246 nm,咖啡因、马来酸氯苯那敏用262 nm。结果对乙酰氨基酚、咖啡因、马来酸氯苯那敏分别在0.1055～2.11μg(r=0.9999)、0.245～7.35μg(r=0.9997)、0.04216～0.8432μg(r=0.9999)与峰面积有良好的线性关系;平均回收率分别为98.7%、98.6%、101.1%(n=9)。结论所用方法操作简便、准确、重复性好,可用于复方氨酚烷氨片的质量控制。OBJECTIVE To develop a method for determination of paracetamol,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablets.METHODS The chromatography was performed on C18 column with 1% acetic acid solution（pH was regulated to 3.7 with diethylamine）-methanol（62：38）as the mobile phase.Paracetamol was detected at 246 nm while caffeine and chlorphenamine maleate were detected at 262 nm.RESULTS The linear ranges of paracetamol,caffeine and chlorphenamine maleate were 0.1055-2.11 μg（r=0.9999）,0.245-7.35 μg（r=0.9997） and 0.04216-0.8432 μg（r=0.9999）,respectively.Their average recoveries（n=9） were 98.7%,98.6% and 101.1%,respectively.CONCLUSION This method is simple,accurate and reproducible,and can be used for controlling the quality of Compound paracetamol and amantadine hydrochloride tablets.

关 键 词：复方氨酚烷氨片 对乙酰氨基酚 咖啡因 马来酸氯苯那敏 含量测定 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]