复方利福平片溶出度测定方法的研究

Study on methods for the compound rifampicin tablets determination

目的 建立复方利福平片的溶出度测定方法。方法 采用溶出度测定法第二法 ,以水为溶剂 ,转速为 5 0r/min ,经 45min取样 ,紫外分光光度法在 474nm处测定利福平的溶出量 ,溶出限度为标示量的 75 %。结果 利福平在 10 3～ 36 1μg/ml范围内线性关系良好 (r =1 0 0 0 0 ) ,平均回收率 99 8%。结论 本方法准确、快速、简便。通过测定复方利福平片的溶出度可有效检测其制剂工艺水平。

Objective To establish a method for the determination of compound rifampicin tablets dissolution. Methods The dissolution test were conducted according to pharmacopoeia of People′s Republic of China, using water as the solvent, with a rotational speed of 50r/min, the solution was withdrew after exactly 45min. The absorbances of dissolution solutions were measured at 474 nm. No less than 75% of the labelled amount is dissolved. Results Good linear relation was achieved when the rifampicin concentration was at the range of 10.3～36.1μg/ml (r=1.0000). The mean recovery rate was 99.8%. Conclusion The method was accurate, rapid and simple for examination of the process of compound rifampicin tablets.