目的 建立HPLC对注射用头孢孟多酯钠中有关物质进行测定的方法。方法 菲罗门Luna C₁₈(2)色谱柱(250 mm×4.6 mm,5μm),流动相为1%三乙胺溶液(用磷酸调节pH值至2.5)-乙腈(76:24),体积流量为1.5 mL/min,检测波长为254 nm,柱温为40℃,进样量为20μL。采用杂质对照品法外标法计算杂质D,采用加校正因子的主成分自身对照法计算杂质A、E、C。结果 杂质D为主要降解产物,定量限为0.01%,在0.02~0.20μg与峰面积线性关系良好。杂质A、E、C的校正因子分别为1.14、1.25、1.14,检测限分别为0.004%、0.02%、0.04%。结论 杂质D、A、E、C作为特定杂质应订入质量标准,可以更好地控制注射用头孢孟多酯钠中有关物质。

Objective To establish an HPLC method for determination of related substances in Cefamandole Nafate for injection. Methods HPLC method was adopted. The determination was performed on Phenomenex C₁₈ (2) column (250 mm×4.6 mm, 5 μm), mobile phase was 1% triethylamine solution (phosphoric acid adjusted pH to 2.5)-acetonitrile (76:24) at a flow rate of 1.5 mL/min. The detection wavelength was set at 254 nm, the column temperature was at 40℃, and the injection volume was 20 μL. Impurity D was determined by external standard method, and impurity A, E, and C were determined by principal component self control method with correction factor. Results Impurity D was the main degradation products, the quantitative limits was 0.01%, and there had good linearity in the ranges of 0.02-0.20 μg/mL. The correction factors of impurity A, E and C were 1.14, 1.25, and 1.14, respectively, and the detection limits were 0.004%, 0.02%, and 0.04%, respectively. Conclusion Impurity D, A, E, and C should be adopted into the quality standard as specific impurities which can better control the related substances in Cefamandole Nafate for injection.