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GC-MS法同时测定盐酸决奈达隆中的3种甲磺酸酯
引用本文:刘立云,张倩如,孙连福,王曼曼,郭文敏. GC-MS法同时测定盐酸决奈达隆中的3种甲磺酸酯[J]. 中国药师, 2014, 0(8): 1274-1276
作者姓名:刘立云  张倩如  孙连福  王曼曼  郭文敏
作者单位:石药集团中奇制药技术(石家庄)有限公司 新型药物制剂与辅料国家重点实验室 石家庄050035;石药集团中奇制药技术(石家庄)有限公司 新型药物制剂与辅料国家重点实验室 石家庄050035;石药集团中奇制药技术(石家庄)有限公司 新型药物制剂与辅料国家重点实验室 石家庄050035;石药集团中奇制药技术(石家庄)有限公司 新型药物制剂与辅料国家重点实验室 石家庄050035;石药集团中奇制药技术(石家庄)有限公司 新型药物制剂与辅料国家重点实验室 石家庄050035
基金项目:科技部“十二五”重大新药创制课题(编号:2011ZX09202-101-21)
摘    要: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 ~ 625.0ng·ml-1,r =0.999 4,甲磺酸乙酯的检测限为0.0375 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.

关 键 词:盐酸决奈达隆  甲磺酸酯  测定  气相-质谱联用
收稿时间:2014-01-21
修稿时间:2014-04-30

Simultaneous Determination of Three Kinds of Methanesulfonates in Dronedarone Hydrochloride by GC-MS
Liu Liyun,Zhang Qianru,Sun Lianfu,Wang Manman and Guo Wenmin. Simultaneous Determination of Three Kinds of Methanesulfonates in Dronedarone Hydrochloride by GC-MS[J]. China Pharmacist, 2014, 0(8): 1274-1276
Authors:Liu Liyun  Zhang Qianru  Sun Lianfu  Wang Manman  Guo Wenmin
Affiliation:CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., State Key Laboratory of New Pharmaceutical Preparations and Excipients,Shijiazhuang 050035, China;CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., State Key Laboratory of New Pharmaceutical Preparations and Excipients,Shijiazhuang 050035, China;CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., State Key Laboratory of New Pharmaceutical Preparations and Excipients,Shijiazhuang 050035, China;CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., State Key Laboratory of New Pharmaceutical Preparations and Excipients,Shijiazhuang 050035, China;CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., State Key Laboratory of New Pharmaceutical Preparations and Excipients,Shijiazhuang 050035, China
Abstract:Objective: To establish the determination method for methyl methanesulfonate, ethyl methanesulfonate and isopropyl mesylate in lurasidone hydrochloride by GC-MS. Methods: The three kinds of methanesulfonates were determined by pre-column deri- vation technology and GC-MS. Results: The detection limit of methyl methanesulfonate was 0. 003 75 ng · ml-1, and the linear cali- bration curve was obtained over the range of 2.0-625.0 ng ·ml -1( r = 0. 999 4). The detection limit of ethyl methanesulfonate was 0. 003 75 ng· ml -1 , and the linear calibration curve was obtained over the range of 2.0-625.0 ng · ml - 1 ( r = 0. 999 8 ). The detec- tion limit of isopropyl mesylate was 0.003 75 ng·ml- 1 , and the linear calibration curve was obtained over the range of 2.0-625.0 ng · ml-1 (r = 0. 999 8). The recovery was 99.89% ,98.98% and 100.36% with RSD of 3.67% ,2.82% and 3.47% ( n = 9), respec- tively. Conclusion: The method is simple, accurate and rapid, and suitable for the determination and quality control.
Keywords:Lurasidone hydrochloride   Methanesulfonate   Determination   GC-MS
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