新药盐酸川汀特罗杂质检查

Analysis of impurities of new compound trantinterol hydrochloride

目的:对盐酸川汀特罗在工艺过程中产生的杂质进行测定。方法:采用高效液相色谱法进行分析,同时采用二极管阵列检测器进行色谱峰纯度检测,液质联用法确定主要杂质的结构。结果:盐酸川汀特罗和杂质峰分离度良好,主要杂质确证为盐酸马布特罗。结论:本法简便、准确,可用于盐酸川汀特罗有关物质检查。

Objective： To analyze the impurities which were produced in the process of preparation of trantinterol hydrochloride. Methods： The HPLC method was applied for the analysis of trantinterol hydrochloride and its impurities, the diode array detector was used to detect the puriy of the chromatographic peak and the structure of main impurity was identified by LC-MS. Results： Trantinterol could be well separated from other impurities, the main impurity was mabuterol hydrochlorlde. Conclusion： The method is simple , accurate and can be used for the annlysis of the impurities of trantinterol hydrochloride.