GC法测定盐酸索他洛尔中有机溶剂残留量

Determination of residual organic solvents in Sotalol Hydrochloride by GC

目的建立气相色谱法测定盐酸索他洛尔中有机溶剂残留量的方法。方法采用气相色谱法,FID检测器,在毛细管色谱柱DB-624（30 m×0.53 mm,3μm）上程序升温,载气为氮气,进样口温度200℃,检测器温度200℃,以二甲基亚砜为溶剂配制对照溶液及供试品溶液。结果四种有机溶剂完全分离,在所考察的浓度范围内具有良好的线性。甲醇、乙醇、乙醚、吡啶的检测限分别为3.66、4.25、1.39、1.25μg.mL-1,精密度RSD均小于3.5%,平均回收率在99.8%~101.6%范围内。结论经方法学验证,本方法简便灵敏,结果准确可靠,适用于盐酸索他洛尔原料药中有机溶剂残留量的检测。

Obiective To establish a method for determining the residues of four kinds of organic solvents in Sotalol Hydrochloride by gas chromatography.Methods The FID detector and the DB-624（30 m×0.53 mm,3 μm） column were used and the column temperature adopted temperature programming.N2 was the carrier gas.The injector temperature was 200 ℃,and the detector temperature was 200 ℃.The dimethylsulfoxide（DMSO） was solvent media to prepare contrast solution and test solution.Results Four kinds of organic solvents separated completely.It appeared a good linear relationship in the experimental concentration.The detector limits of methanol,ethanol,diethyl ether,pyridine respectively were 3.66,4.25,1.39,1.25 μg·mL-1.The RSDs of precision were all less than 3.5%.The range of average recovery was 99.8%～101.6%.Conclusion The method was simple,sensitive,accurate,can be used for the determination of residual solvents in Sotalol Hydrochloride.