目的对HPLC法测定流感疫苗中游离甲醛残留量的不确定度进行评定。方法通过分析测量过程,确定并简化不确定度来源,经统计学方法,量化不确定度分量,计算合成不确定度和扩展不确定度。结果 HPLC法测定流感疫苗中游离甲醛残留量和不确定度结果可表示为(8.04±0.24)μg/ml,k=2。结论该方法适用于流感疫苗中游离甲醛残留量的不确定度评定,可为测定游离甲醛残留量提供依据。 OBJECTIVE To evaluate the uncertainty of HPLC method for the determination of free formaldehyde residues in influenza vaccines. Methods By analyzing the measurement process, the source of uncertainty is determined and simplified, and the uncertainty components are quantified through statistical methods to calculate the synthetic uncertainty and extended uncertainty. Results The HPLC method was used to determine the residual amount and uncertainty of free formaldehyde in the influenza vaccine. The results can be expressed as (8.04 ± 0.24) μg / ml, k = 2. Conclusion The method is suitable for the evaluation of the uncertainty of free formaldehyde residues in influenza vaccine and can provide the basis for the determination of free formaldehyde residue.