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目的:对采用HPLC法测定格列本脲的含量进行测量不确定度评价。方法:通过建立不确定度的数学模型,分析测定过程中的各不确定度分量,并对测定中的各影响因素进行考察。结果:格列本脲的扩展不确定度为1.5%,相对扩展不确定度为1.6%,格列本脲的含量结果可表示为(93.1±1.5)%。结论:使格列本脲含量测定的过程得到有效的控制。
Objective: To evaluate the uncertainty of measurement of glyburide by HPLC. Methods: Through the establishment of a mathematical model of uncertainty, the components of the uncertainty in the determination process were analyzed, and the various influencing factors in the determination were investigated. Results: The extended uncertainty of glibenclamide was 1.5% and the relative expanded uncertainty was 1.6%. The content of glyburide could be expressed as (93.1 ± 1.5)%. Conclusion: The process of determination of glyburide can be effectively controlled.