UPLC测定注射用头孢哌酮钠舒巴坦钠

目的: 建立超高效液相色谱检测注射用头孢哌酮钠舒巴坦钠含量及有关物质的方法。 方法: 采用ACQUITY UPLC HSS C₁₈色谱柱,以0.1%磷酸水溶液和乙腈为流动相进行梯度洗脱,流速0.45 mL·min^-1,检测波长为220 nm,柱温为30 ℃。 结果: 头孢哌酮与舒巴坦在20~150 μg·mL^-1范围内r≥0.9998,各杂质均呈良好的线性关系;头孢哌酮平均回收率为99.9%,RSD为0.40%;舒巴坦平均回收率为99.5%,RSD为0.36%;重复性、专属性、供试品溶液稳定性良好,各组分之间互相无干扰。 结论: 该方法专属性强、灵敏度高、准确性好,可以作为注射用头孢哌酮钠舒巴坦钠含量测定及有关物质检查的有效方法。

Objective:To develop a UPLC method for determination the contents and related substances of cefoperazone sodium and sulbactam sodium for injection.Methods：Using ACQUITY UPLC HSS C₁₈(2 mm×100 mm,1.8μm),the mobile phase was 0.1% phosphoric acid and acetonitrile at a gradient with a flow rate of 0.45 mL·min^-1 and detection wavelength was 220 nm,column temperature was 30 ℃.Results：The linear ranges of cefoperazone and sulbactam were 20-150 μg·mL^-1(r≥0.9998)respectively,and the related substances were good linear relationship.The average recovery of cefoperazone was 99.9% with RSD of 0.41%, and sulbactam was 99.5% with RSD of 0.37%;This method had fine repeatability,specificity,good stability of the test solution,no interference among the components was appearance.Conclusion： The HPLC method is good in the aspect of selectivity, sensitivity and veracity, can be used to detect the contents and impurities of cefoperazone sodium and sulbactam sodium for injection.