毛细管气相色谱法检测右丙亚胺中的残留溶剂

Capillary gas chromatographic determinatio of residual solvents in dexrazoxane

目的:建立毛细管气相色谱法定量检测右丙亚胺原料药中的残留溶剂。方法:色谱柱为OV-101(30 m×0.53 mm,1μm),柱温采用程序升温,载气为氮气,采用氢离子火焰检测器;以1,2-二氯乙烷为内标,测定右丙亚胺中的有机残留溶剂为甲醇、二氧六环、N,N-二甲基甲酰胺。结果:在本色谱条件下,测得各组分的线性关系良好(r均在0.9965以上);平均回收率分别为100.1%、99.8%、99.0%;最低检测限分别为0.1024、0.199、0.448μg.mL-1。结论:方法灵敏,准确,适用于右丙亚胺中残留溶剂的检测。

Objective： To establish a GC method for the determination of the residual solvents in dexrazoxane. Methods： The chromatographic systems included a OV-101 column（30 m × 0. 53 mm, 1 μm）, nitrogen gas used as cartier gas and a FID as detector. The programmed heating method was adopted temperature control was established. Results： The linear ranges of residual solvents methanol, dioxane and N, N-dimethylformamidewere fairly good （ r 〉 0. 996） and their recoveries were 100. 1%, 99. 8% ,99. 0%, respectively. The minimum detection were 0. 1024,0. 199,0. 448 μg·mL^-1 , respectively. Conclusion： This method is sensitive and accurate, and suitable for determination of residual solvents in dexrazoxane.