超高效液相色谱法测定注射用头孢替唑钠的有关物质

Determination of related substances in ceftezole sodium for injection by UPLC

目的：建立超高效液相色谱梯度洗脱法测定注射用头孢替唑钠中的有关物质。方法：采用Waters Acquity UPLC BEH C18（100 mm×2.1 mm,1.7μm）色谱柱,以枸橼酸溶液（取枸橼酸3 g加水溶解并稀释至900 ml）-乙腈（90∶10）为流动相A,乙腈为流动相B,线性梯度洗脱;流速：0.3 ml/min;检测波长：254 nm。结果：在0.19～47.08μg/ml浓度范围内,头孢替唑峰面积与浓度呈良好的线性关系（r=1.000 0）。结论：本法简便快速、专属性强,可作为测定注射用头孢替唑钠有关物质的有效方法。

Objective： To develop a UPLC method for determination of the related substances in Ceftezole Sodium for Injection.Methods： Waters Acquity UPLC BEH C18column（ 2. 1 mm × 100 mm,1. 7 μm） was adopted. Citric acid solution（ 3 g of citric acid in 900 ml of water）- acetonitrile（ 90∶ 10） was used as mobile phase A,and acetonitrile as mobile phase B. Gradient elution was applied. The flow rate was 0. 3 ml / min. The detection wave length was at 254 nm. Results： The linear range of ceftezole sodium was between 0. 19 μg / ml and 47. 08 μg / ml（ r = 1. 000 0）. This method manifested fine repeatability,specificity and good stability of the test solution. Conclusion： This method is convenient,quick,specific and suitable for determination of the related substances of Ceftezole Sodium for Injection.