HPLC法测定盐酸氨溴索注射液中有关物质

Determination of related substances in Ambroxol Hydrochloride Injection by HPLC

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 MPC18柱(250mm×4.6mm,5μm),以磷酸氢二铵缓冲液(pH4.0)-甲醇(40:60)为流动相,体积流量为1.0mL/min,检测波长为250nm,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、30ng;杂质的线性范围为0.72～1.68μg/mL(r=0.9996),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-dibromo-phenyl） 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.