利巴韦林纯度标准物质的定值及不确定度评估研究  

Purity Determination and Uncertainty Evaluation of Ribavirin Purity Reference Material

作　　者：杜慧[1] 邢逞[1] 史永强 杜冠华[3] 吕扬[1,2] 

机构地区：[1]北京协和医学院、中国医学科学院药物研究所晶型药物北京市重点实验室,北京100050 [2]山东省晶型药物重点实验室,滕州277500 [3]北京协和医学院、中国医学科学院药物研究所药物靶点研究与新药筛选北京市重点实验室,北京100050

出　　处：《医药导报》2014年第6期779-784,共6页Herald of Medicine

基　　金：重大新药创制十二五规划项目(2012ZX09301002-001-013,2013ZX09102110);卫生部行业基金资助项目(200902008)

摘　　要：目的以利巴韦林为研究对象,研制具有可溯源和量值传递功能的国家级计量有证标准物质,并建立有效定值分析方法。方法采用差示扫描量热法(DSC)对利巴韦林纯度标准物质进行均匀性和稳定性检验;采用DSC和高效液相色谱(HPLC)法中两种不同原理方法联合定值,建立不确定度评估的数学模型。结果利巴韦林纯度标准物质具有良好的均匀性和稳定性,纯度标准值和不确定度值为(99.5±0.4)%(k=2,P=0.95)。结论研制的利巴韦林纯度标准物质属国家一级有证计量标准物质(GBW09587),该标准物质可作为量值溯源与量值传递的计量器具,其研究结果可为我国药品质量控制提供标准物质、物质标准与标准方法,实现与国际接轨目标。Objective To develop the ribavirin purity certified reference material （CRM） which has measurement traceability and high accuracy, and establish an effective method of evaluation. Methods The homogeneity and the stability were checked by differential scanning calorimetry （DSC）. High performance liquid chromatography （HPLC） and DSC methods were used for purity determination of ribavirin. Results Ribavirin showed satisfactory homogeneity and stability. The certified value of ribavirin was 99.5 % with an uncertainty of 0.4% （ k = 2, P = 0.95 ）. Conclusion Ribavirin purity CRM obtained in this paper has been proven to be a national primary CRM with high accuracy and traceability, which can be used to validate analytical methods, improve the accuracy of measurement data, establish meteorological traceability of analytical results as well as control the quality of ribavirin in the pharmaceutical industry.

关 键 词：利巴韦林 纯度标准物质 量热法 差示扫描 色谱法 高效液相 

分 类 号：R978.7[医药卫生—药品] R927.1[医药卫生—药学]