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气相色谱法测定托吡酯中有机溶剂的残留量 被引量:2

Determination of residual organic solvents in TOPAMAX by GC
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摘要 目的建立抗癫痫药托吡酯中残留有机溶剂的含量测定方法。方法用气相色谱仪,采用DB-Wax(30 m×0.32 mm,0.25μm)毛细管柱;分流比:30∶1;进样口温度:150℃;柱温:初始温度45℃保持6 min,以25℃.min-1的速度升至150℃,保持4.5min;FID检测器温度:275℃;载气:N2;载气流速:1.5 mL.min-1;进样量:1.0μL。结果各残留溶剂线性关系良好,相关系数均大于0.99,回收率均在90%~110%之间。结论该方法操作简单,重复性好,灵敏度高,适用于托吡酯中残留溶剂的含量测定。 Abstract: Objective To establish a GC method for determination of residual organic solvents in topamax by GC. Methods The capil- lary column DB-Wax(30 m xO. 32 mm,O. 25 I^m)was used. Split ratio was 30:1 ;the injector temperature was 150℃. The column tem- perature was set at 45 ℃ for 6 min and then programmed at 25 ℃ min-i to 150 ℃ and held for 4.5 min;FiD temperature was 275℃ with 1.5 ml · min - 1 as N2 flow rate; Volume of injection was 1.0 μL. Results The calibration curve of residual organic solvents was lin- ear( RSD 〉 0.99 ) ;The recoveries were between 90% and 110%. Conclusion The method is simple, repeatable and reliable. This method can be used for the determination of residual organic solvents in topamax.
出处 《安徽医药》 CAS 2013年第6期955-958,共4页 Anhui Medical and Pharmaceutical Journal
关键词 气相色谱 托吡酯 残留有机溶剂 方法验证 GC TOPAMAX residual organic solvents method verification
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