论文部分内容阅读
目的:建立同时测定盐酸决奈达隆中甲磺酸甲酯,甲磺酸乙酯,甲磺酸异丙酯含量的方法。方法:采用柱前衍生技术,利用GC-MS法,测定盐酸决奈达隆中三种甲磺酸酯的含量。结果:甲磺酸甲酯的检测限为0.003 75 ng·ml-1,线性范围为2.0~625.0 ng·ml-1,r=0.999 4,甲磺酸乙酯的检测限为0.037 5 ng·ml-1,线性范围为2.0~625.0 ng·ml-1,r=0.999 8,甲磺酸异丙酯的检测限为0.375 ng·ml-1,线性范围为2.0~625.0 ng·ml-1,r=0.999 8。回收率分别为99.89%,98.98%,100.36%,RSD分别为3.67%,2.82%,3.47%(n=9)。结论:该方法简便,准确,快速,适用于盐酸决奈达隆质量控制和检测。
OBJECTIVE: To establish a method for the simultaneous determination of methyl methanesulfonate, ethyl methanesulfonate and isopropyl mesylate in dronedarone hydrochloride. Methods: Pre-column derivatization was used to determine the content of three mesylate esters in dronedarone hydrochloride by GC-MS method. Results: The detection limit of methyl methanesulfonate was 0.003 75 ng · ml-1, the linear range was 2.0-625.0 ng · ml-1, r = 0.999 4. The detection limit of ethyl methanesulfonate was 0.037 5 ng · ml -1, the linear range was 2.0-625.0 ng · ml-1, r = 0.999 8. The detection limit of isopropyl mesylate was 0.375 ng · ml-1 with a linear range of 2.0-625.0 ng · ml-1, r = 0.999 8. The recoveries were 99.89%, 98.98% and 100.36%, respectively, with RSDs of 3.67%, 2.82% and 3.47%, respectively (n = 9). Conclusion: The method is simple, accurate and rapid and suitable for the quality control and testing of dronedarone hydrochloride.