目的 采用HPLC 法测定盐酸氨溴索注射液中的有关物质。方法 采用Agela Venusil MP C18 柱（250 mm×4.6 mm， 5 μm），以磷酸氢二铵缓冲液（pH 4.0）–甲醇（40∶60）为流动相，体积流量为1.0 mL/min，检测波长为250 nm，柱温： 30 ℃。结果 盐酸氨溴索和反式-4-[6,8-二溴-1,4-二氢喹唑啉-3(2H)]环己醇的最小检出限分别为15、30 ng；杂质的线性范 围为0.72～1.68 μg/mL（r=0.999 6），加样平均回收率为101.32%，RSD 为0.92%（n=9）。结论 该方法测定盐酸氨溴索注 射液中的有关物质方法简便、准确、专属性强。

Objective To develop a method for the determination of related substances in Ambroxol Hydrochloride Injection. Methods The analysis was performed on an Agela Venusil MP C18 column (250 mm×4.6 mm, 5 μm). The mobile phase was ammonium dibasic phosphate buffer (pH 4.0)-methanol (40:60) with flow rate at 1.0 mL/min. The detection wavelength was 250 nm and column temperature was 30 ℃. Results The minimum detection limit of ambroxol hydrochloride and trans-4-[[(2-amino-3,5-dibromophenyl) methyl] amino]-cyclohexanol was 15 ng and 30 ng, respectively. The calibration curve of impurity was linear in the range of 0.72—1.68 μg/mL (r=0.999 6); An average recovery rate of 101.32% was obtained with RSD 0.92% (n=9). Conclusion This method is simple, accurate and with good specificity and could be used to determine the related substances in Ambroxol Hydrochloride Injection.

“十二五”重大新药创制科技重大专项项目（2011ZX09201-101-19）；国家重点基础研究发展计划项目（2010CB735602）