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目的:建立同时测定SIPI5357甲磺酸盐中甲磺酸甲酯、甲磺酸乙酯、甲磺酸异丙酯的方法。方法:采用柱前衍生技术和GC-MS,按内标曲线法进行SIPI 5357甲磺酸盐中甲磺酸甲酯、甲磺酸乙酯、甲磺酸异丙酯的含量测定。结果:3个杂质之间分离度均大于2.0,线性范围为2.0~625.0 ng·mL-1,r=0.999 9,(n=6),方法准确度>99.9%,精密度RSD<3.1%,检出限均小于0.375 ng·mL-1。结论:该方法简便、准确、快速,适用于SIPI 5357甲磺酸盐质量控制和检测。
Objective: To establish a method for the simultaneous determination of methyl mesylate, ethyl mesylate and isopropyl mesylate in SIPI5357 mesylate. Methods: The contents of methyl mesylate, ethyl mesylate and isopropyl mesylate in SIPI 5357 mesylate were determined by means of internal standard curve method using column precolumn derivatization and GC-MS. Results: The separation between the three impurities was more than 2.0 with a linear range of 2.0-625.0 ng · mL-1, r = 0.999 9 (n = 6), accuracy of 99.9%, precision RSD <3.1% The detection limits were less than 0.375 ng · mL-1. Conclusion: The method is simple, accurate and rapid and suitable for the quality control and testing of SIPI 5357 mesylate.