高效液相色谱法测定利福昔明混悬乳剂的含量

摘要

A method for the content determination of Rifaximin suspoemulsion by HPLC was established.HPLC system consisted of C18 column(5 μm 4.6×150 mm), Methyl alcohol-Acetonitrile-Citric acid-Potassium Phosphate Monobasic(32∶28∶25∶4) as mobile phase.The flow rate was 1.0 mL/min.The detection wave length was 236 nm.The injection volume was 20 μl and column temperature was room temperature.There was no interference occurred from inpurities.The calibration curve was linear in the range of 5～100 μg/mL(r2=0.9996).The recovery was 98.4％～100.2％ and RSD was 0.58％～1.32％.The method is rapid, simple and accurate for the content determination of Rifaximin suspo-emulsions.%建立了测定利福昔明混悬乳剂含量的高效液相色谱法(HPLC).采用C18色谱柱(4.6 × 150 mm,5 μm),以甲醇-乙腈-0.075 mol/L磷酸二氢钾溶液-1 mol/L柠檬酸溶液(32∶28∶25∶4)为流动相,流速1.0 mL/min,检测波长236 nm,进样量20 μL,柱温25℃.利福昔明浓度在5～100 μg/mL时,其峰面积与浓度线性关系良好(r2=0.9996),无杂质干扰,稳定性高,回收率范围为98.4％～100.2％,RSD为0.58％～1.32％.本操作方法简便,分析快速,结果准确,适用于利福昔明混悬乳剂的含量测定.