HPLC法测定头孢泊肟酯分散片中有关物质的含量

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

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。

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.