舒巴坦匹酯原料残留溶剂的评价

Evaluation of Residual Solvent in Sulbactam Pivoxil

目的:建立测定舒巴坦匹酯中残留溶剂的方法。方法:对挥发性较强的二氯甲烷、乙酸乙酯、乙醇采用气相色谱顶空进样法测定;对不宜挥发的N,N-二甲基甲酰胺(DMF)采用气相色谱直接进样法测定含量,限度与欧洲药典1999年增补版的标准一致。结果:二氯甲烷、乙酸乙酯和乙醇在2～400μg·ml^(-1),N,N-二甲基甲酰胺在7～680μg·ml^(-1)范围内呈良好的线性关系。结论:本方法简便、快速、准确。

Objective: To establish a determining a method for the residual solvent in sulbactam pivoxil. Method: The stronger volatilizing methylene dichloride, ethyl acetate, ethanol were determined by displacing sampling of vapor-phase chroma tography, the content of unsuitable volatilizing N, N-dimethylformamide was determined by direct sampling of vopor-phase chroma tography, the limit was identical with Eur. Pharmacopoeia(Suppl). Result:There were good linear correlation of methylene dichloride, ethyl acetate, ethanol in range of 2-400/Mg-ml and N, N-dimethylformamide in range of 7-680/ig-ml ' . Conclusion; This method is simple, rapid, and accurate.