梯度洗脱HPLC法测定头孢丙烯中的有关物质

Quality control of cefprozil by HPLC

目的用梯度洗脱高效液相色谱法测定头孢丙烯中的有关物质。方法采用Hypersil C18色谱柱，流动相A为pH4.2缓冲液，流动相B为甲醇，二元梯度洗脱，检测波长283nm。结果头孢丙烯浓度在1.0～50μg·mL^-1范围．内线性关系良好（r=0．9999）；最低检测限为0.06μg·mL^-1；各有关物质与主成分均达到基线分离。结论本法可用于有关物质检查。

Objective To establish a method for quality control of cefprozil. Methods HPLC analysis was performed on an Hypersil C18 column with a linear gradient elution consisting of methanol and aqueous ammonium dihydrogen phosphate （ pH4.2 ）. The detection wavelength was at 283 nm. Results The calibration curve was linear in the range of 1.0 -50 μg/mL（ r = 0. 9999）. The detection limit of cefprozil was 0. 06 μg/mL. Conclusion This method can be use for quality control of cefprozil.