目的 建立测定注射用头孢唑肟钠中有关物质的HPLC法。方法 采用Agient Eclipse C₁₈色谱柱（250 mm×4.6 mm，5 μm）；以乙腈–pH 3.6缓冲液（取枸橼酸1.42 g、磷酸氢二钠2.31 g，加水溶解并稀释至1 000 mL）为流动相，进行梯度洗脱；检测波长：254 nm；柱温：40℃；体积流量：0.8 mL/min；进样量20 μL。结果 头孢唑肟在0.24～14.52 μg/mL与峰面积呈良好的线性关系（r=1.000 0），最低检出质量浓度0.03 μg/mL。结论 采用的HPLC方法简单、专属性强，可有效控制注射用头孢唑肟钠产品的质量。

Objective To establish a method for the determination of related substances in Ceftizoxime Sodium for injection by HPLC. Methods The determination was carried out on Agient Eclipse C₁₈ column (250 mm × 4.6mm, 5 μm) with the mobile phase containing acetonitrile-buffer solution (pH 3.6) (dissolve citric acid monohydrate 1.42 g and disodium hydrogen phosphate dodecahydrate 2.31 g in water and diluted to 1 000 mL) with gradient elution. The detective wavelength was set at 254 nm. The temperature of column was set 40℃. The flow rate was 0.8 mL/min with injection volume of 20 μL. Results The linearity range of ceftizoxime sodium was 0.24-14.52 μg/mL (r=1.000 0), and LOD was 0.03 μg/mL. Conclusion The method is simple and selective to be used for the quality control of Ceftizoxime Sodium for injection products effectively.