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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 HSSC18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20～150μg.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 establish a method for the determination of cefoperazone sodium and sulbactam sodium for injection and related substances by ultra performance liquid chromatography. Methods: ACQUITY UPLC HSSC18 was used with gradient elution with 0.1% phosphoric acid and acetonitrile as the mobile phase at a flow rate of 0.45 mL · min-1. The detection wavelength was 220 nm and the column temperature was 30 ℃. Results: Cefoperazone and sulbactam showed a good linear relationship among all impurities in the range of 20-150 μg · mL-1. The average recoveries of cefoperazone was 99.9% and RSD was 0.40% The average recovery was 99.5% with a RSD of 0.36%. Repeatability and specificity were good for the stability of the test solution without any interference between the components. Conclusion: The method is specific, sensitive and accurate, and can be used as an effective method for the determination of cefoperazone sodium and sulbactam sodium for injection and the related substances inspection.