| 摘要 |
[Objectives] To establish an LC-MS method for the determination of dibromoacetic acid in Cefathiamidine and Cefathiamidine for Injection. [Methods] Shiseido PC HILIC column (2.0 mm×100 mm, 3 μm) was used. The mobile phase was 0.005 M ammonium formate and the mobile phase was acetonitrile with gradient elution. The flow rate was 0.3-0.8 mL/min. [Results] The limit of detection was 0.250 0 ng/mL and the limit of quantification was 0.500 ng/mL, which were 2.5% and 5.0% of the impurity limits, respectively. The recovery rate was 103.85%. [Conclusions] This method improved the detection of dibromoacetic acid impurities in Cefathiamidine, and has that advantage of good specificity, low limit of detection and limit of quantification, high sensitivity, high accuracy, interference resistance, can meet the detection requirements of Cefathiamidine, and is suitable for the quality control of Cefathiamidine. |
