HPLC-PDA方法同时检测黄连解毒散中非法添加的对乙酰氨基酚和盐酸溴己新

Simultaneous Determination of Acetaminophen and Bromhexine Hydrochloride Illegally Added in the Huanglian Jiedu Powder by HPLC-PDA

关键词:  对乙酰氨基酚  盐酸溴己新  黄连解毒散  HPLC-PDA

Key words:  acetaminophen  bromhexine hydrochloride  Huanglian Jiedu Powder  HPLC-PDA

摘要:

为同时检测黄连解毒散中非法添加的对乙酰氨基酚和盐酸溴己新，以十八烷基键合硅胶为填充剂，1%冰醋酸溶液（用三乙胺调剂pH值至4.0）为流动相A，甲醇为流动相B，进行梯度洗脱，流速为1.0 mL/min，波长扫描范围为210~400 nm，柱温25 ℃，建立了HPLC-PAD检测方法，并采用峰纯度检查和光谱相似度检查辅助对照品比对方法，对非法添加药物进行确证。结果显示，对乙酰氨基酚和盐酸溴己新的回收率分别为98.6%和99.4%，RSD分别为0.6%和0.2%；线性方程分别为y=43408x-401.96，R2=1和y=14331x-1682.4，R2=1；检测限分别为1和5 mg/g；定量限分别为2和10 mg/g。本方法简洁、灵敏、可靠，可同时对黄连解毒散中非法添加的对乙酰氨基酚和盐酸溴己新违禁药物进行定性和定量检测。

Abstract:

A method for the simultaneous determination of acetaminophen and bromhexine hydrochloride illegally added in the Huanglian Jiedu Powder was developed by the high performance liquid chromatography with photo-diode array detector (HPLC-PDA). It was tested with C18 column, using 1% acetic acid solution(adjusting pH to 40 by triethylamine) and methanol with gradient elutionas the mobile phase. The scanning wavelength was from 210 to 400 nm.Peak purity test and spectrum similarity test were used to identify the illegally added drugs.The mean recoveries of acetaminophen and bromhexine hydrochloride was 98.6% and 99.4%, respectively. RSD was 0.6% and 0.2%, respectively. In conclusion, the method is simple, accurate and reliable for the determination of acetaminophen and bromhexine hydrochloride in the Huanglian Jiedu Powder.