法莫替丁中残留溶剂二甲基甲酰胺的测定

Determination of residual dissolvent dimethyl-formylamine in famotidine

采用气相色谱法测定了“三步法”新工艺生产的法莫替丁成品中残留溶剂二甲基甲酰胺的残留量 ,浓度在 0 0 30 2～ 0 .0 112 1mg·mL-1 范围内具有良好的线性关系 该方法变异系数为 2 0 6 % ,回收率为 99 5 %

The gas chromatography method (GCM)was used for determining the residual quantity of dimethyl formylamine existed in raw drug famotidine,which was made by new process“Three-step Method' The concentration had good linear relation under the range of 0.0302～0.01121 mg·mL -1 .The coefficient of variation was 2.06% and the recovery rate was 99.5%.