甲苯磺酸索拉非尼原料中残留溶剂的测定  

Determination of the residual solvents in sorafenibtosylate

作　　者：骆雪芳[1,2] 郁健[1] 陈志[3] 赖建生 

机构地区：[1]中国药科大学理学院药物质量研究中心,南京210038 [2]中国药科大学药物质量与安全预警教育部重点实验室,南京210009 [3]安庆医药高等专科学校,安庆246052 [4]杭州凯明庞德生物科技有限公司,杭州311121

出　　处：《西北药学杂志》2017年第3期310-313,共4页Northwest Pharmaceutical Journal

摘　　要：目的研究甲苯磺酸索拉非尼溶剂残留简便快速、准确灵敏的检测方法。方法以正丁醇为内标物,用Agilent DB-WAX(30m×0.45mm,0.85μm)色谱柱,采用直接进样法检测,FID为检测器。结果包括内标在内的8个组分最小分离度为2.71,回收率为98.1%~110.9%(n=9),RSD值为4.1%~7.3%。结论直接进样法可同时分析包括高沸点组分DMF在内的多个残留溶剂,方法简便快速、准确灵敏。Objective To establish a simple,quick,accurate and sensitive method for the determination of residual solvents in sorafenibtosylate.Methods N-butyl alcohol was used as the internal standard substance.An Agilent DB-WAX（30m×0.45 mm,0.85μm）column,a flame ionization detector,and direct sampling method were used.Results The minimum resolution factor of 8components in sample solution was 2.71.The recovery of residual solvents were 98.1%-110.9%（n=9）,and RSD were 4.1%-7.3%.Conclusion Direct sampling method in GC is simple,quick,accurate and sensitive for analyzing residual solvents including dimethylfuran.

关 键 词：甲苯磺酸索拉非尼 溶剂残留 直接进样法 

分 类 号：R927.2[医药卫生—药学]