HPLC法测定注射用头孢唑肟钠中主药的含量

Determination of Main Component in Ceftizoxime Sodium for Injection by HPLC

目的:建立以高效液相色谱法测定注射用头孢唑肟钠中主药含量的方法。方法:色谱柱为ODS-AC18,流动相为磷酸盐缓冲液-乙腈(9∶1),检测波长为254nm,流速为1mL·min-1,进样量为20μL,柱温为40℃。结果:头孢唑肟检测浓度的线性范围为16～24μg·mL-1(r=0.9996);平均回收率100.6%,精密度为0.45%,最低检测限为1ng。结论:本方法操作简便、灵敏度高、结果准确,可用于该制剂的含量测定。

OBJECTIVE： To establish a HPLC method for the content determination of ceftizoxime in ceftizoxime sodium for injection.METHODS：The column was ODSA C18 with column temperature of 40℃ , and the mobile phase was phosphate acid buffer solution - acetonitrile（9 ： 1） .The detection wavelength was 254nm and the sample size was 20μL. RESULTS： The standard curve of ceftizoxime sodium was liner in the range of 16-24μg · mL^-1（r= 0.999 6） with average recovery rate at 100.6% and precision at 0.45%. The lowest detectable limit was lng. CONCLUSION： The method is simple, sensitive and accurate. It can be applied to the content determination of ceftizoxime sodium for injection.