HPLC法测定头孢氨苄中L-头孢氨苄杂质的研究

Determination of impurity L-Cefalexin in Cefalexin by HPLC

为检测头孢氨苄中杂质的含量,特建立此方法用于测定头孢氨苄中杂质L-头孢氨苄含量。采用HPLC法,色谱条件为采用CAPCELL PAK C18 MG‖色谱柱,将0.1 mol/L磷酸二氢钠(p H值为5.0)为流动相A,甲醇为流动相B,采用梯度洗脱,流速1.5 m L/min在220nm波长处测定。经对此方法进行方法验证,头孢氨苄和L-头孢氨苄在此条件下分离度良好,专属性、准确度、重复性、检测限、定量限等均满足要求。经方法学验证结果表明,本法可用于对头孢氨苄原料中L-头孢氨苄的质量控制。

In order to detect the content of impurities in Cefalexin,this method was established to determine the content of impurity L-Cefalexin in Cefalexin.HPLC was adopted,the chromatographic conditions were as follows,CAPCELL PAK C18 MG‖column was used,0.1mol/L sodium dihydrogen phosphate(pH5.0)was used as mobile phase A,methanol was used as mobile phase B,gradient elution was adopted,the flow rate was 1.5 mL/min and the determination was carried out at 220nm wavelength.We have conducted method validation.It confirms that the separation degree of Cefalexin and L-Cefalexin was good under this condition,and the specificity,accuracy,repeatability,detection limit and quantitative limit all met the requirements.The method can be used for the quality control of L-Cefalexin.