RP-HPLC测定盐酸氨溴索葡萄糖注射液中有关物质  

Determination of Related Substances in Ambroxol Hydrochloride and Glucose Injection by RP-HPLC

作　　者：夏瑞[1] 代红[1] 车宝泉[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国现代应用药学》2009年第6期496-498,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的采用RP-HPLC测定盐酸氨溴索葡萄糖注射液中的有关物质。方法采用RP-HPLC,C18柱,以0.1mol·L-1醋酸铵溶液-甲醇(40∶60)为流动相;检测波长为246nm。结果杂质B相对于盐酸氨溴索的校正因子为1.47,盐酸氨溴索和杂质B的最低检出限分别为0.75ng和1.5ng,盐酸氨溴索与其他杂质峰的分离度符合要求。结论采用RP-HPLC测定盐酸氨溴索葡萄糖注射液中的有关物质方法简便、灵敏、专属性强。OBJECTIVE To develop a method for the determination of related substance in dmbroxol hydrochloride and glucose injection by RP-HPLC. METHODS The analysis was performed on a C18 column, The mobile phase consisted of 0.1 mol·L^-1 ammonium acetate solution-methanol （40 ： 60）. The detection wavelength was 246 nm. RESULTS The response factor of impurity B relative to that of ambroxol hydrochloride was 1.47. Ambroxol hydrochloride and related substances could be well separated. The limit of detection of ambroxol hydrochloride and impurity B was 0.75 ng and 1.5 ng, respectively. CONCLUSION This method can be used to simultaneously separate and determine the related substances in ambroxol hydrochloride and glucose injection. It is simple and accurate.

关 键 词：盐酸氨溴索 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]