依达拉奉标准物质中乙醇残留的测定

Determination of Ethanol Residual Solvents in Edaravone Standard Substance

建立了依达拉奉标准物质中乙醇残留量的气相色谱测定方法,其中色谱柱为DB-624（30 m×0.32 mm×1.8 μm）,柱温为220℃;进样口温度为250℃;火焰离子检测器温度为250℃.结果表明乙醇在0.0053～0.1282 mg/mL范围内呈良好的线性关系,相关因子r为1.0000;平均回收率为99.73 ％（RSD=0.51％）,3批样品中有关物质乙醇的含量均低于0.09％.因此经方法学验证,该方法灵敏度、精密度均达到有机溶剂残留量的检测要求,可用于依达拉奉中乙醇的测定.

To establish a capillary gas chromatography （GC） method for the determination of ethanol in edaravone standard substance. Wherein the gas chromatography column was DB-624 （30 m×0.32 mm× 1.8 μm）, the column temperature was 220 ℃, the injection port temperature was 250℃, the temperature of FID was 250 ~C. The results showed that the concentration of ethanol was within 0.0053-4）.1282 （r=1.0000）. The recovery of ethanol was 99.73 % and the RSD was 0.51%. The concentration of ethanol in three batches of samples was lower than 0.09 %. So the method was proven to be sensitive and accurate after the validation. It is suitable for the detennination of residual organic solvents of ethanol in edaravone.