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目的评定HPLC测定注射用长春西汀含量的不确定度,确定引入测量不确定度的主要来源,以便在检验检测工作中引起重视并及时纠正。方法分析测量不确定度的来源,建立相关数学模型。并计算各分量引入的不确定度,合成标准不确定度和扩展不确定度。结果 HPLC测定注射用长春西汀含量扩展不确定度为1.5%,含量范围为96.6%±1.5%(k=2)。结论对照品的称取和供试品溶液的配制是测量不确定度的主要来源,故在测定时应对其加以控制和关注。
Objective To assess the uncertainty of determination of vinpocetine in injection by HPLC and to determine the main sources of measurement uncertainty in order to pay more attention to the detection and detection and to correct it in time. Methods Analyze the sources of measurement uncertainty and establish related mathematical models. The uncertainties introduced by each component, the synthetic standard uncertainty and the extended uncertainty are calculated. Results The determination of vinpocetine in injection had an extended uncertainty of 1.5% and a content range of 96.6% ± 1.5% (k = 2). Conclusion The weighing of the reference substance and the preparation of the test solution are the main sources of measurement uncertainty, so it should be controlled and focused on the determination.