格列美脲纯度标准物质的定值及不确定度的评定  

Certification and uncertainty evaluation of glimepiride purity certified reference material

作　　者：冯云潇[1] 郭永辉 刘玉真[1] 姜建国 

机构地区：[1]河北科技大学,河北石家庄050011 [2]河北省药品检验研究院,河北石家庄050011

出　　处：《中国医院药学杂志》2016年第8期677-681,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:对格列美脲纯度标准物质进行定值及不确定度研究。方法:采用波谱法对格列美脲进行定性分析;采用HPLC法和酸碱滴定法进行纯度测定;建立格列美脲纯度标准物质不确定度评定方法。结果:研制的格列美脲纯度标准物质符合一级标准物质的要求,纯度值及不确定度为99.70%±0.90%(k=2,P=0.95)。结论:研制出的格列美脲标准物质量值具有可溯源性和准确性,可用于药品质量控制。OBJECTIVE To determine purity of glimepiride,and establish a method of uncertainty evaluation.METHODSUV,IR and HPLC-MS/MS were used to confirm structure of glimepiride.HPLC and acid-base titration were used to determine purity of glimepiride.Measurement uncertainly of glimepiride purity material was established.RESULTS Structure of glimepiride was confirmed by spectral analysis.Purity of prepared glimepiride was 99.70 %±0.90 %（k=2,P=0.95）.This standard glimepiride fit criteria specified in Chinese Pharmacopeia.CONCLUSION Glimepiride prepared in this study can be used as a standard material in pharmaceutical analysis.

关 键 词：格列美脲纯度标准物质 高效液相色谱法 酸碱滴定法 标准值及不确定度 

分 类 号：R917[医药卫生—药物分析学]