氢化可的松栓稳定性测定方法的研究

Study on the Methods for Testing the Stability of Hydrocortisone Suppository

目的 :研究氢化可的松栓稳定性的测定方法。方法 :用HPLC、UV和TTC三种方法对相同批次的氢化可的松栓进行含量测定 ,其结果与相关样品的薄层色谱图作比较。结果 :三种方法对零月样品测定结果几乎一致。对 6月 ,1 2月样品的测定结果 ,HLPC法与TTC法相近 ,且与薄层色谱相对应 ,能正确反映主药含量。结论

Objective:Study and comparison the methods for testing the stability of hydrocortisone suppository.Methods:Determination of the same samples of hydrocortisone suppository with the methods of HPLC,UV Spectrophotometry and Red Tetrazolium Spectrophotometry,and the results were further compared and explained with thin-layer chromatogram.Results:For the fresh samples there were little difference in the results from the three methods,but for the samples stored for six months and twelve months,only the results by HPLC and Red Tetrazolium Spectrophotometry were similar and showed correctly the contents of main component.It can also be explained by thin-layer chromatogran.Conclusions:The methods of HPLC and Red Tetrazolium Spectrophotometry were relizable to test the stability of hydrocortisone suppository.