HPLC法测定头孢特仑酯片中主药的含量

Determination of Main Component Content in Cefteram Pivoxil Tablet by HPLC

目的:建立以高效液相色谱法测定头孢特仑酯片中主药含量的方法。方法:色谱柱为C18,流动相为乙腈-水(40:60),流速为1.2mL.min-1,柱温为40℃,检测波长为235nm,进样量为10μL。结果:头孢特仑酯检测浓度的线性范围为25～125μg.mL-1(r=0.9999,n=7);平均回收率为104.98%,RSD=0.86%。结论:本方法简便、快速、准确,可用于该制剂的质量控制。

OBJECTIVE： To establish an HPLC method for the determination of cefteram pivoxil content in cefteram pivoxil tablet. METHODS： The chromatography column was C18 with column temperature set at 40 ℃ ; and the mobile phase consisted of acetonitrile- water （40 ： 60） at a flow rate of 1,2 mL . min ^-1. The detection wavelength was 235 nm and the sample size was 10 μL. RESULTS： The linear range of cefteram pivoxil was 25- 125 μg . mL ^-1（ r = 0.999 9, n = 7）, and the average recovery was 104.98% （RSD = 0,86%） , CONCLUSION： The method is simple, rapid, accurate and sensitive, and suitable for the quality control of cefteram pivoxil tablet.