复方呋塞米螺内酯胶囊质量控制方法的研究  

Study of the quality control of the compound furosemide and spironolactone capsules

作　　者：上官可可 李美珍[2] 杨金荣[2] 房志仲[2] 

机构地区：[1]天津医科大学第二医院药剂科,天津300211 [2]天津医科大学药学院药剂学教研室,天津市临床药物关键技术重点实验室,天津300070

出　　处：《天津医科大学学报》2016年第1期80-83,共4页Journal of Tianjin Medical University

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。Objective： To develop a method for controlling the quality of compound FuSpirC. Methods： High performance liquid chromatography was used to determine the contents of furosemide and spironolactone in compound FuSpirC. Results： Column was represented by Kromasil-Cls （200 mm×4.6mm, 5μm）, mobile phase was methanol： 0.02 mol/L potassium dihydrogen phosphate （67：33） （used 0.85% phosphoric acid adjust pH 4.3）, flow rate 0.8 mL/min, detected wavelength was 239 nm, the concentrations of furosemide and spironolactone were 5-35μg/mL and 20-80 μg/mL, 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 were lO1.76%（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 than 2%, 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 forquality control of compound FuSpirC.

关 键 词：呋塞米 螺内酯 高效液相色谱法 质量控制 

分 类 号：R927.2[医药卫生—药学]