【摘要】 目的:建立复方呋塞米螺内酯胶囊(Fu Spir C)的质量控制方法。方法:用高效液相色谱法测定复方制剂中呋塞米和螺内酯的含量。结果:色谱柱:Kromasil C18柱(200 mm×4.6 mm,5μm),流动相为甲醇∶0.02 mol/L磷酸二氢钾(67∶33)(0.85%磷酸调节p H至4.3),流速0.8 m L/min,检测波长为239 nm,呋塞米、螺内酯分别在5~35μg/m L、20~80μg/m L浓度范围线性关系良好,呋塞米平均回收率分别为98.29%(RSD=0.08%,n=3)、99.20%(RSD=0.48%,n=3)、99.18%(RSD=0.36%,n=3),螺内酯平均回收率分别为101.76%(RSD=0.13%,n=3)、101.35%(RSD=0.52%,n=3)、101.67%(RSD=0.27%,n=3),平均回收率的RSD均小于2%,符合方法学要求,呋塞米、螺内酯平均含量分别为94.79%、99.76%,均符合要求。结论:所建立方法可用于复方呋塞米螺内酯胶囊的质量控制。更多还原

【Abstract】 Objective: To develop a method for controlling the quality of compound Fu Spir C. Methods: High performance liquid chromatography was used to determine the contents of furosemide and spironolactone in compound Fu Spir C. Results: Column was represented by Kromasil-C18(200 mm×4.6 mm,5 μm), mobile phase was methanol: 0.02 mol/L potassium dihydrogen phosphate(67:33)(used 0.85% phosphoric acid adjust p H 4.3), flow rate 0.8 m L/min, detected wavelength was 239 nm, the concentrations of furosemide and spironolactone were 5 ~35 μg/m L and 20 ~80 μg/m L, respectively, and were in good linear relationship. The average recovery rate of furosemide were 98.29%(RSD = 0.08%,n =3),99.20%(RSD = 0.48%,n =3),99.18%(RSD = 0.36%,n =3), while spironolactone were101.76%(RSD = 0.13%,n=3),101.35%(RSD = 0.52%,n=3),101.67%(RSD = 0.27%,n=3), the average recovery of RSD was less than2%, conformed to the requirement of the methodology. The content of furosemide and spironolactone were 94.79% and 99.76%,conformed to the requirements. Conclusion: The methods can be used for quality control of compound Fu Spir C.更多还原