利福平胶丸中有关物质测定的改进及溶出度测定方法的建立

The improvement the method for the determination of related substance and establishment of dissolution in Rifampicin soft capsules

目的改进了利福平胶丸中有关物质及建立了溶出度测定的方法。方法采用HPLC测定有关物质,采用紫外分光光度法测定溶出度。结果 HPLC法测定利福平胶丸中有关物质的分离度良好,紫外法测定溶出度的结果良好。结论所用方法准确、灵敏度高、重复性好,可有效地控制药品的质量。

OBJECTIVE To establish method for the determination of Rifampicin soft capsules （RSC） related substance and dissolu- tion. METHODS The determination of related substance was established by HPLC and dissolution was established by the UV absorp- tion Spectrophotophotometry. RESULTS The Rifampicin was sperated from its related substances completely by HPLC. The UV and visible spectra of dissolution was suitable for RSC. CONCLUSION The method is accurate, sensible and reproducible. The method is suitable for the quality control.