盐酸托烷司琼国家一级化学纯度标准物质研究

Study of National Primary Purity Certified Reference Material of Tropisetron Hydrochloride

关键词:  盐酸托烷司琼  纯度标准物质  高效液相色谱法  差示扫描量热法

Key words:  tropisetron hydrochloride  purity certified reference material  HPLC  differential scanning calorimetry

摘要:

目的 通过准确可靠的定值方法及不确定度分析研究，研制具有可溯源和量值传递功能的盐酸托烷司琼国家一级化学纯度标准物质。方法 以5-HT₃受体拮抗剂盐酸托烷司琼为研究对象，根据我国计量法和一级标准物质研制技术规范与相关技术文件要求，采用HPLC对盐酸托烷司琼纯度标准物质进行均匀性和稳定性检验；采用HPLC和差示扫描量热法2种不同原理方法联合定值，并完成不确定度评估。结果 研制的盐酸托烷司琼纯度标准物质具有良好的均匀性和稳定性，纯度标准值为99.7%，不确定度为0.4%（k=2）。结论 研制的盐酸托烷司琼为国家一级标准物质（GBW09494）。该研究可实现相关成分的量值溯源及量值传递，同时为我国药品的标准化和现代化提供了重要的标准物质和标准分析方法。

Abstract:

OBJECTIVE To develop the national primary purity certified reference material(CRM) of tropisetron hydrochloride which has measurement traceability and value transfer function through establishing accurate, reliable analytical method of valuation and uncertainty. METHODS The 5-HT₃ receptor antagonist tropisetron hydrochloride was used as the study object. The homogeneity and the stability were checked by HPLC. The purity of tropisetron hydrochloride CRM was certified by the joint certification including HPLC and differential scanning calorimetry, and the uncertainty was carefully evaluated on the basis of Technical Norm of Primary Reference Material and related documents requirements. RESULTS Tropisetron hydrochloride CRM showed satisfactory homogeneity and stability. The purity of tropisetron hydrochloride CRM was 99.7% and the uncertainty was 0.4%(k=2). CONCLUSION The national primary CRM of tropisetron hydrochloride developed has been assigned as a grade primary reference material(GBW09494). The study enables measurement traceability and value transfer of related components, as well as provides important reference material and standard analysis methods for the standardization and modernization of medicines.