摘要
目的:建立供含量测定用的比沙可啶对照品。方法:将比沙可啶原料药精制后获得比沙可啶精制品,通过UV、IR、DSC等手段进行鉴别,并用TLC、HPLC、DSC、电位滴定等多种方法进行纯度分析及含量测定。结果:TLC法表明其有关物质的量低于1%;HPLC、DSC法、电位滴定法测得的比沙可啶精制品的绝对含量分别为99.6%、99.5%、100.6%。结论:比沙可啶精制品的纯度符合供含量测定用对照品的要求。
Objective：To establish the reference standard of bisacodyl for assay. Method： The refined bisacodyl was obtained by purify of bisacodyl bulk drug, and was identified by UV, IR and DSC; its purity and absolute content were determined by the method of TLC, HPLC, DSC and potentiometric titration. Result： The related substances of refined bisacodyl was below 1% determined by TLC; The absolute contents of refined bisacodyl obtained by the method of HPLC, DSC and potentiometric titration were 99.6%, 99.5%, and 100.6%, respectively. Conclusion： The purity of refined bisacodyl comply with the requirement of reference standard for assay.
出处
《中国药师》
CAS
2009年第7期860-862,共3页
China Pharmacist
关键词
比沙可啶
对照品
含量测定
Bisacodyl
Reference standard
Content delermination
