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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 study the value and uncertainty of glimepiride purity standard substance. Methods: Qualitative analysis of glimepiride was carried out by spectroscopic method. The purity of glimepiride was determined by HPLC and acid-base titration. The uncertainty of glimepiride purity standard was evaluated. Results: The purity standard of glimepiride developed met the requirements of primary standard substance. The purity and uncertainty were 99.70% ± 0.90% (k = 2, P = 0.95). Conclusion: The standard value of glimepiride developed has traceability and accuracy, which can be used for the quality control of medicines.