HPLC法测定利福昔明干混悬剂中利福昔明的含量

Determination of rifaximin in Rifaximin Dry Suspension by HPLC

目的:建立高效液相色谱法测定利福昔明干混悬剂中利福昔明的含量限度的方法。方法:采用高效液相色谱法,色谱柱为Kromasil C8,甲醇-乙腈-0.075mol/L磷酸二氢钾溶液-1.0mol/L枸橼酸溶液(50∶22.5∶22.5∶5)为流动相,流速为1.0ml/min,检测波长为240nm。结果:利福昔明在41.02～164.08μg/ml范围内线性关系良好(r=0.99997),平均回收率为99.79%,RSD为1.30%,规定含量限度为90.0%～110.0%。结论:本法准确、灵敏、可靠,能有效地控制该制剂的质量。

Objective： To establish a method for the determination of rifaximin in Rifaximin Dry Suspension by HPLC. Methods： HPLC was used, the chromatographic column was Kromasil Cs, with the methyl alcohol-methyl cyanide -0.075 mol/L potassium dihydrogen phosphate solution-1.0 mol/L citron acid solution （50：22.5：22.5：5） as the mobile phase, the flow rate was 1.0 ml/min, the detective wavelength was set at 240 nm. Results： The calibration curve of rifaximin was linear at the range of 41.02-164.08 μg/ml （r=0.999 97）, the average recovery was 99.79%, RSD=1.30%, the content limit was 90.0%- 110.0%. Conclusion： This method is accurate, sensitive and reliable, it can be used for the quality control of this preparation effectively.