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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 method for the determination of residual solvent in sulbactam. Methods: The most volatile dichloromethane, ethyl acetate and ethanol were determined by GC headspace sampling. The non-volatile N, N-dimethylformamide (DMF) was determined by gas chromatography direct injection Determination of content, the limit and the European Pharmacopoeia 1999 supplement version of the same standards. Results: There was a good linear relationship between dichloromethane, ethyl acetate and ethanol in the range of 2 ~ 400μg · ml ~ (-1) and N, N-dimethylformamide in the range of 7 ~ 680μg · ml ~ (-1) . Conclusion: This method is simple, rapid and accurate.