HPLC法测定头孢呋辛酯及制剂中小分子有关物质及聚合物

Determination of small-molecule related substances and polymer in cefuroxime axetil and its preparation by HPLC

目的建立可同时测定头孢呋辛酯及制剂中小分子有关物质及聚合物的HPLC方法。方法采用C_8色谱柱,以0.05mol/L磷酸二氢铵溶液为流动相A,甲醇为流动相B,梯度洗脱,检测波长278nm。结果头孢呋辛酯对照溶液在1~503μg/mL范围内,线性关系良好(r=1.0000),最低检出限为0.25μg/mL。头孢呋辛酯与有关物质分离完全,可检出头孢呋辛酯聚合物。结论本方法操作简便,专属性强,结果可靠,可用于头孢呋辛酯及制剂中小分子有关物质及聚合物的测定。

Objective To establish an HPLC method for the determination of small-molecule related substances and polymer in cefuroxime axetil and its preparation. Methods A C8 column was used, with the mobile phase A of 0.05mol/L ammonium dihydrogen phosphate solution, and the mobile phase B of methanol, by the gradient elution at the detection wavelength of 278mn. Results The calibration curve of cefuroxime axetil solution was linear in the concentration range of 1-503μg/mL （r=1.0000）, and the detection limit of cefuroxime axetil is 0.25μg/mL. The peak of the related substances and cefuroxime axetil could be separated well. The polymer of cefuroxime axetil can be detected. Conclusion The method is simple, specific and reliable, and it is suitable to determine the small molecule related substances and polymer of cefuroxime axetil and its preparation.