高效液相色谱法测定头孢噻吩钠含量和有关物质

建立高效液相色谱法（HPLC）测定头孢噻吩钠含量和有关物质。色谱条件以C18为固定相,色谱柱：（4.6mm×250mm,5μm）;流动相为0.207mol/L醋酸钠溶液（用冰醋酸调pH值至5.9）-乙醇-乙腈（82：2：16）,流速为：1.0mL/min;检测波长：254nm：柱温;40℃。结果：头孢噻吩钠含量在55.8μg/mL至464.4μg/mL呈良好线性关系,r=0.9999：平均回收率100.2%;最低检测限为3ng（1ng/μL×3μL）。本法简单、准确,重现性、分离效果好,能较好的进行孢噻吩钠含量和有关物质测定。

Content determination of cefalotin sodium and its related substances by high performance liquid chromatography

Objective：To study the high performance liquid chromatography（HPLC） method for the determination of cefalotin sodium and its related substances.Methods：The chromatographic conditions are as follow： column：C18（4.6mm×250mm,5μm）;mobile phase：0.207mol/L Sodium acetate aqueous solution（adjusted to pH 5.9 with acetic acid）-ethanol-acetonitrile（82： 2： 16）;flow rate： 1.0mL/min;detection wavelength：254nm;column temperature： 40℃.Results：The calibration cure of assay is linear when the concentration of cefalotin sodium in the range of 55.8～464.4μg/ml,r=0.9999,and the average recovery 100.2%.The limit of detection is 3ng（1ng/μl×3μl）.Conclusion：The method is simple and accurate with good reproducibility.It provides a new and reliable means for the quality control to content determination of cefalotin sodium and its related substances.