建立GC法测定多肽药物中乙醇、乙腈、乙醚和异丙醇含量的方法,以FID为检测器,按照外标法计算含量。经考察,该方法具有专属性,各溶剂浓度与峰面积的直线回归系数均大于0.999,各溶剂的加标回收率均在80%~120%,重复性和中间精密度考察RSD均小于5.0%,乙醇、乙醚、异丙醇和乙腈的定量限分别为3.58、2.58、3.57、3.10μg/m L,并具有良好的耐用性,可用于多肽原料药中残留溶剂的分析。 To establish a method for the determination of ethanol, acetonitrile, diethyl ether and isopropanol in the peptide drugs by GC method, the FID was used as the detector to calculate the content according to the external standard method. After investigation, the method is specific, the linear regression coefficients of each solvent concentration and peak area are greater than 0.999, the spiked recoveries of each solvent are in the range of 80% ~ 120%, repeatability and intermediate precision RSD are less than 5.0% , The limit of quantification of ethanol, ether, isopropanol and acetonitrile were 3.58,2.58,3.57 and 3.10μg / m L, respectively, and had good durability, which could be used for the analysis of residual solvents in peptide drug substance.