注射用头孢孟多酯钠中有关物质的HPLC测定

Determination of Related Substances in Cefamandole Nafate for Injections by HPLC

建立了高效液相色谱法测定注射用头孢孟多酯钠中的有关物质。选择BDS Hypersil C_(18)色谱柱,以0.05 mol/L甲酸铵溶液(用甲酸调至pH 4.5,A)∶乙腈(B)为流动相,线性梯度洗脱,检测波长254 nm。结果主成分头孢孟多酯与相邻杂质,以及各杂质之间均能分离完全,并确定了已知有关物质A、C、D、E的相对保留时间。头孢孟多酯在1~10μg/ml范围内线性关系良好。本方法重复性好、灵敏度高,适用于注射用头孢孟多酯钠中有关物质的分析。同时本研究采用主成分自身对照法,定性、定量测定了不同批次产品中的有关物质A、C、D、E,旨在更好地控制产品质量。

An HPLC method was established for the determination of the related substances in cefamandole nafate for injection. A BDS Hypersil C18 column was used, with the mobile phase of ammonium formate solution （adjusted to pH 4.5 by formic acid, A） ： acetonitrile （B）, at the detection wavelength of 254 nrn. The resolutions between cefamandole nafate and the neighbouring peaks as well as the resolutions between the impurities all met the requirements. The relative retention time of the known related substances A, C, D and E were determined. It was linear for cefamandole nafate in the range of 1-10 μg/ml. The established method, which was proved to be suitable and sensitive, can be applied to analyze the related substances including A, C, D and E by principal component self-control method in cefamandole nafate of different batches and to provide a better control of the product quality.