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目的对高效液相色谱法(HPLC)测定替硝唑片中替硝唑含量的不确定度进行分析和评价。方法通过建立替硝唑含量测定的数学模型,找出影响不确定度的主要因素并对各不确定度分量进行评估。结果本次替硝唑片中替硝唑含量测定结果为标示量的94.1%,其扩展不确定度为1.3%(k=2)。结论本试验所建立的不确定度评估方法适用于HPLC法测定替硝唑片含量的不确定度评定。
Objective To analyze and evaluate the uncertainty of determination of tinidazole in tinidazole tablets by high performance liquid chromatography (HPLC). Methods By establishing the mathematical model of tinidazole determination, the main factors influencing the uncertainty were found out and the uncertainty components were evaluated. Results The tinidazole content in tinidazole tablets was 94.1% of the labeled amount, with an extended uncertainty of 1.3% (k = 2). Conclusion The uncertainty assessment method established in this study is suitable for the evaluation of the uncertainty of HPLC method for the determination of tinidazole tablets.