RP-HPLC法同时测定注射用替卡西林钠克拉维酸钾中两个主成分的含量

目的:建立同时测定注射用替卡西林钠克拉维酸钾中两个主要成分含量的RP-HPLC方法。方法:采用SB-Aq色谱柱(250mm×0.46mm,5μm);流动相为0.05mol/L磷酸二氢钠溶液(pH5.2)-0.05mol/L磷酸二氢钠溶液(pH4.3)-乙腈,进行梯度洗脱;流速1.0mL/min,柱温25℃,检测波长220nm。结果:标准曲线中替卡西林和克拉维酸的浓度分别为103.7～311.1μg/mL和6.666～20.00μg/mL;相关系数分别为0.999和0.999;平均加样回收率(n=9)分别为99.6%和99.3%。结论:该方法准确性好、灵敏度高、重复性好,可有效控制药品生产质量。

RP-HPLC simultaneous determination of two main components in ticarcillin disodium-clavulanate potassium for injection

Objective：To develop a method for simultaneous determination of two main components in ticarcillin disodium-clavulanate potassium for injection by RP-HPLC.Methods：A SB-Aq column（250mm×0.46mm,5μm） was used with 0.05 mol/L sodium dihydrogen phosphate（pH5.2）-0.05 mol/L sodium dihydrogen phosphate（pH4.3）-acetonitrile as mobile phase under gradient elution.The flow rate was 1.0mol/L,the column temperature was 25℃.The detection wavelength was 220nm.Results：The standard curves were linear in the range of 103.7～311.1μg/mL（r=0.999） for ticarcillin and 6.666～20.00μg/mL（r=0.999） for clavulanic acid,and the recoveries were 99.6% and 99.3% for ticarcillin and clavulanic acid,respectively.Conclusion：The method has high sensitivity,accuracy and reproducibility,and can control the quality of pharmaceuticals effectively.