HPLC法测定头孢泊肟酯分散片中有关物质的含量

目的:建立测定头孢泊肟酯分散片中有关物质含量的方法。方法:采用高效液相色谱法。色谱柱为ODS(C18)柱,流动相为水-甲醇(55:45),流速为2.0mL·min-1,检测波长为240nm,柱温为25℃,进样量为20μL。结果:头孢泊肟酯A、头孢泊肟酯B与杂质能完全分离;头孢泊肟酯A最小检测限为1.6ng,头孢泊肟酯B最小检测限为1.2ng,其有关物质含量均<4.0%。结论:该方法简便、准确,灵敏度高,专属性强,可用于头孢泊肟酯分散片有关物质含量的测定。

Content Determination of Related Substance in Cefpodoxime Proxetil Dispersible Tablet by HPLC

OBJECTIVE： To establish the method for the content determination of the related substances in Cefpodoxime proxetil tablet. METHODS： HPLC method was adopted. The determination was performed on ODS （C18） column with water-methanol （55：45） as mobile phase at the flow rate of 2.0 mL.min^-1. The detection wavelength was set at 240 nm and column temperature was 25 ℃. Injection volume was 20 μL. RESULTS： Cefpodoxime proxetil A and cefpodoxime proxefil B could be separated from impurity completely. The lowest detectable limit of cefpodoxime proxetil A was 1.6 ng and that of cefpodoxime proxetil B was 1.2 ng. The contents of the related substances were less than 4.0%. CONCLUSION： The method is convenient, accurate, sensitive and specific. It is suitable for the content determination of the related substances in Cefpodoxime proxetil dispersible tablet.