高效液相色谱法测定盐酸氨溴索口服溶液中杂质B的含量  

HPLC determination of the content of impurity B in Ambroxol hydrochloride oral solution

作　　者：陈丽艳 孙玉蓉 陆秋波 

机构地区：[1]衡阳市第一精神病医院药剂科,湖南衡阳421002

出　　处：《中南药学》2014年第10期1025-1027,共3页Central South Pharmacy

摘　　要：目的 建立HPLC法测定盐酸氨溴索口服溶液中杂质B[反式-4-（6,8-二溴-四氢喹唑啉环己醇）盐酸盐]的含量。方法 用Agilent TC-C18色谱柱,以乙腈-0.01 mol.L-1磷酸氢二铵（50：50）为流动相,UV检测波长为248 nm,室温下测定盐酸氨溴索口服溶液中杂质B的含量。结果 杂质B在1.242 5～49.7μg.mL^-1呈良好的线性关系,r=0.999 9,回收率为99.4%,RSD为0.86%（n=3）。结论 该方法专属性,简单可行,为更好的控制盐酸氨溴索口服溶液质量提供参考。Objective To establish an HPLC method to determine the content of impurity B [trans-4-（6,8-dibromo-1, 4-dihydroquinazolin-3（2H）-yl） cyclohexanol hydrochloride] in Ambroxol hydrochlorid oral solution. Methods The analysis was performed on a Agilent TC-C18 column at room temperature, the mobile phase was consisted of acetonitrile-0.01 mol·L-1 ammonium hydrogen phosphate（50 ：50）, the detection wavelength was 248 nm. Results The standard curve was linear at 1.242 5- 49.7 μg·mL^- 1, r = 0.999 9, the average recovery was 99.4%, and RSD was 0.86%（n = 3）. Conclusion The method is specifi c, simple and feasible, which provids reference for the quality control of Ambroxol hydrochloride oral solution.

关 键 词：盐酸氨溴索 杂质B 校正因子 

分 类 号：R917[医药卫生—药物分析学]