顶空气相色谱法测定头孢氨苄原料中残留溶剂

Determination of residual solvents in cefalexin by headspace gas chromatography

目的建立顶空气相色谱法测定头孢氨苄中有机残留溶剂甲醇、丙酮、二氯甲烷、甲基异丁基酮、甲苯的含量。方法以0.1 mol.mL-1的盐酸溶液为溶剂制备对照品及供试品溶液,以DB-624毛细管柱为分离柱,采用程序升温。结果 5个成分的线性关系良好,方法精密度、重复性均符合要求。结论该方法适用于测定头孢氨苄原料中残留溶剂甲醇、丙酮、二氯甲烷、甲基异丁基酮、甲苯的含量。

Objective To establish a method for determination of residual methanol,acetone,dichlormethane,methyl isobutyl ketone and methylbenzene in cefalexin by headspace gas chromatography.Methods The solvent of the preparation of the sample sloution and standard sample were 0.1 mol·mL-1 HCL,DB-624 capillary column was adopted.The temperature programming was used.Results The five compositions had good linear relation in the linear ranges,the precision and reproducibility of the method were accord with the requests.Conclusion This method could be used to determine residual methanol,acetone,dichlormethane,methyl isobutyl ketone and methylbenzene in cefalexin.