川皮苷纯度标准物质的定值及不确定度评估

Purity assignment and uncertainty evaluation of certified reference material of nobiletin

中文关键词:  川皮苷  标准物质  定量核磁法  质量平衡法

英文关键词:nobiletin  certified reference material  quantitative nuclear magnetic method  mass balance method

中文摘要:

      目的 建立川皮苷纯度标准物质(certified reference material, CRM)的定值方法并对标物研制过程中产生的不确定度进行评估。方法 采用定量核磁法(quantitative nuclear magnetic resonance, qNMR)与质量平衡法2种不同原理的高准确度方法对川皮苷标准物质进行纯度定值分析。对样品分装、定性分析、定值条件优化、均匀性检验、稳定性考察以及不确定度评估进行系统、全面的研究。结果 川皮苷标准物质(GBW(E)100456)纯度质量分数为99.4%, 扩展不确定度为0.4%(k=2), 结论 建立的方法能用于川皮苷及类似纯度标准物质的定值, 川皮苷纯度标准物质均匀性良好, 4 ℃条件下至少稳定6个月, 能够用于农产品、食品、医药、化妆品领域中川皮苷检测及质量控制。

英文摘要:

      Objective To establish purity characterization methods for nobiletin and evaluate the uncertainty arising from the development process of certified reference material (CRM). Methods Two independent methods involving mass balance approach and quantitative nuclear magnetic resonance (qNMR) technique were used in the purity measurement of certified reference material (CRM) of nobiletin. Sample preparation, qualitative analysis, characterization methods optimization, homogeneity study, stability monitoring and uncertainty evaluation were investigated sufficiently．Results The property value of nobiletin CRM was 99.4%, with expanded uncertainty of 0.4% (k=2). Conclusion The established methods can be used as purity characterization methods for nobiletin and similar purity CRM. The homogenous of nobiletin CRM is good and the expiration date of CRM is at least 6 months at 4 ℃. The CRM can be used for agricultural products, food, medicine, cosmetics, nobiletin inspection and quality control.