凝胶色谱法测定注射用盐酸头孢吡肟中的高分子杂质

Quantitative determination of high molecular weight impurities in cefepime hydrochloride injection by Sephadex G-10 column chromatography

目的建立测定注射用盐酸头孢吡肟中高分子杂质(头孢吡肟聚合物)的方法。方法采用分子排阻凝胶色谱自身对照外标法进行定量,用葡聚糖凝胶G-10(40～120μm)为填料,流动相A为0.1mol/L磷酸盐缓冲液(pH=7.0),流动相B为超纯水,流速为1.0mL/min,检测波长为254nm。结果注射用盐酸头孢吡肟的高分子杂质含量均小于0.5%。结论本法快速、简便,可用于注射用盐酸头孢吡肟高分子杂质的质量控制。

Objective To establish a method for determining high molecular weight impurities in cefepime hydrochloride injection. Methods Quantification of high molecular weight impurities in cefepime hydrochloride injection was determined by Sephadex G-10 column chromatography with external standard method.The mobile phase consisted of 0.1 mol/L phosphate buffer（pH7.0） and supper pure water.The flow rate was 1.0 mL/min and detection wavelength 254 nm.Results The content of high molecular weight impurities in different batches of eefepime hydrochloride injection was less than 0.5%.Conclusion This method was sensitive and accurate for determining high molecular weight impurities in cefepime hydrochloride injection.