目的:对国产头孢他啶中共有的杂质H进行研究。方法:制备液相色谱采用Phenomenex Luna C18柱(150 mm×21.2 mm,5μm),流动相A为醋酸盐缓冲液(20 mmol·L-1醋酸铵,用醋酸调节pH为4.0),流动相B为乙腈,梯度洗脱,流速15 mL·min-1,柱温为室温。收集目标物冻干后利用紫外光谱、红外光谱、质谱、核磁共振对头孢他啶杂质H进行结构确认;并利用斑马鱼模式生物比较头孢他啶及其杂质H的胚胎发育毒性。结果:通过实验证实头孢他啶杂质H的结构为(6R,7R)-7-[[(2-氨基-1,3,4-噻唑-4-基)-2-(1-甲氧基2-甲基-1-氧代内烷-2-基)氧亚氨乙酰]氨基]-8-氧代-3-(吡啶-1-鎓-1-基-甲基)-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-甲酸;头孢他啶杂质H在斑马鱼胚胎毒性实验中的致畸作用是头孢他啶的25倍、致死作用是头孢他啶的8倍。结论:头孢他啶杂质H应予以严格控制。 Objective: To study the common impurity H in domestic ceftazidime. METHODS: Preparative liquid chromatography was performed on a Phenomenex Luna C18 column (150 mm × 21.2 mm, 5 μm). The mobile phase A consisted of acetate buffer (20 mmol·L -1 ammonium acetate, adjusted to pH 4.0 with acetic acid), mobile phase B acetonitrile, gradient elution, flow rate 15 mL · min-1, the column temperature was room temperature. The target was lyophilized and the structure of ceftazidime impurity H was confirmed by UV, FTIR, MS and NMR. The zebrafish was used to compare the embryonic developmental toxicity of ceftazidime and its impurity H. Results: The structure of ceftazidime impurity H was confirmed to be (6R, 7R) -7 - [[(2-amino-1,3,4-thiazol- Oxoethanoyl] amino] -8-oxo-3- (pyridin- 1 -en- 1 -yl-methyl) -5-thia-1- Azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid; Ceftazidime impurity H in zebrafish embryo toxicity experiments teratogenic effect of ceftazidime 25 times, lethal effect is 8 times ceftazidime. Conclusion: Ceftazidime impurity H should be strictly controlled.