酒石酸托特罗定有关物质的液质联用鉴定研究  

Identification of the related substances in tolterodine tartrate by LC-MS/MS

作　　者：于艪[1] 宋敏[1] 周霞[1] 杭太俊[1] 

机构地区：[1]中国药科大学药物分析教研室,南京210009

出　　处：《中国新药杂志》2013年第21期2561-2568,2578,共9页Chinese Journal of New Drugs

摘　　要：目的:鉴定酒石酸托特罗定的有关物质。方法:采用LiChrospher C18(250 mm×4.6 mm,5μm)色谱柱,以甲醇-甲酸铵缓冲液为流动相梯度洗脱,对酒石酸托特罗定有关物质进行分离;采用LC-ESI/TOF/MS高分辨测定各有关物质离子的精密质量和元素组成,MS/MS测定二级质谱并进行结构解析。结果:在所建立的条件下,托特罗定及其有关物质分离良好,检测并鉴定出9个有关物质。结论:液质联用技术能有效地分离鉴定酒石酸托特罗定中的有关物质,鉴定结果为其质量控制和工艺优化提供了参考。Objective： To identify the related substances in tolterodine tartrate. Methods： A LiChrospher C18 （250 mm ×4.6 mm, 5 μm） column was used for separation of the related substances with a mixture of methanol and ammonium formate buffer as the mobile phase of gradient elution. The structures of the related substances were identified by LC-TOF high resolution MS detection of their ion composition and MS/MS elucidation. Results： Tolterodine tartrate and the related substances were separated under the established HPLC condition. Nine related substances in tolterodine tartrate were detected and speculated by the hyphenated techniques. Conclusion： The established LC-MS method is effective for separation and identification of the related substances in tolterodine tartrate and the results are useful for its quality control and process optimization.

关 键 词：酒石酸托特罗定 有关物质 结构鉴定 LC-TOF MS LC—MS MS 

分 类 号：R927[医药卫生—药学] R983