HPLC-DAD法测定阿莫西林舒巴坦匹酯分散片中舒巴坦匹酯含量及有关物质

目的:建立以高效液相色谱-二极管阵列检测法测定阿莫西林舒巴坦匹酯分散片中舒巴坦匹酯及有关物质含量的方法。方法:色谱柱为Hypersil BDS,流动相为磷酸二氢钾溶液-乙腈(40∶60),检测器为二极管阵列检测器,检测波长为204nm,扫描范围为300～190nm,流速为1.0mL·min-1,进样量为10μL。结果:舒巴坦匹酯检测浓度的线性范围为119.83～1198.3μg·mL-1(r=0.9999);平均回收率为98.7%(RSD=0.65%);有关物质的含量为1.02%～1.10%。结论:本方法简便、准确,可用于该制剂的质量控制。

Determination of Sulbactam Pivoxil and the Related Substances in Amoxicillin Suibactam Pivoxil Dispersible Tablets by HPLC-DAD

OBJECTIVE： To establish an HPLC-DAD method for the determination of sulbactam pivoxil and the related subsmaces in amoxicillin sulbactam pivoxil dispersible tablets, METHODS： The chromatographic column was Hypersil BDS with mobile phase consisted of potassium dihydrogen phosphate solution ： acetonitrile （40 ： 60） at a flow rate of 1.0 mL ·min^ -1. The detector was diode array detector （DAD） at a detection wavelength of 204 nm and spectrum range of 300-190 nm. The injection volume was 10μL. RESULTS： The linear range of sulbactam pivoxil was 119.83 - 119 8.3μg · mL ^-1（ r = 0.999 9）, with an average recovery rate of 98.7% （RSD = 0.65%） . The content of the related substances was 1.02%-1.10%. CONCLUSION： The method is simple and accurate, and it can be used for the quality control of amoxicillin sulbactam pivoxil dispersible tablets.