目的 建立并验证同时测定流感病毒裂解疫苗（MDCK细胞）中Triton X-100和聚山梨酯80（polysorbate 80，PS80）残留量的方法。方法 采用高效液相色谱（high performance liquid chromato-graphy，HPLC）-蒸发光散射检测器（evaporative light-scattering detector，ELSD）方法检测流感病毒裂解疫苗中的Triton X-100和PS80残留量，并对该方法的专属性、准确度、精密度、线性、定量限和耐用性进行验证。结果 HPLC-ELSD法检测空白溶剂无色谱峰出现，混合标准溶液和供试品可见2个目标色谱峰，且与相邻峰的分离度大于1.5；Triton X-100和PS80样品的不同浓度加标回收率分别在90.0%~105.0%和80.0%~105.0%；同一实验员重复进样6次，TritonX-100和PS80残留量的相对标准偏差(relative standard deviation,RSD)分别为0.7%和1.4%；由2名实验员在不同工作日检测Triton X-100和PS80残留量的RSD均不高于5.0%；Triton X-100质量分数在0.010%~0.100%范围内，浓度与峰面积呈良好的线性关系，定量限为0.010%。PS80质量分数在0.006% ~0.060%范围内，浓度与峰面积呈线性关系，定量限为0.003%。结论 成功建立了流感病毒裂解疫苗（MDCK细胞）中Triton X-100和PS80残留量的HPLC-ELSD检测方法，该方法具有良好的专属性、准确度、精密度、线性和耐用性。

Objective To establish and validate a method for the simultaneous determination of residual Triton X-100 and polysorbate 80 (PS80) in influenza virus split vaccine (MDCK cell).Methods Triton X-100 and PS80 residues in influenza virus split vaccine were detected by high performance liquid chromatography (HPLC)-evaporative light-scattering detector (ELSD) method. The specificity, accuracy, precision, linearity, limit of quantitation and robustness of this method were verified.Results In the HPLC-ELSD analysis, no chromatographic peaks were observed in blank solvent. Two target chromatographic peaks were visible in both mixed standard solution and test sample, with the resolution from adjacent peaks greater than 1.5. The spiked recovery rates of Triton X-100 and PS80 at various concentrations were 90.0%-105.0% and 80.0%-105.0%, respectively. When the same experimenter performed repeated injections six times, the relative standard deviations (RSDs) of Triton X-100 and PS80 contents were 0.7% and 1.4%, respectively. When two inspectors determined the residual amounts of Triton X-100 and PS80 on different working days, the RSDs were both ≤ 5.0%. When Triton X-100 mass fraction was in the range of 0.010%-0.100%, a good linear relationship was observed between the concentration and peak area, with limit of quantitation at 0.010%. When PS80 mass fraction was in the range of 0.006%-0.060%, a linear relationship was found between the concentration and peak area, and the limit of quantitation was 0.003%.Conclusions HPLC-ELSD detection method for Triton X-100 and PS80 residues in influenza virus split vaccine is successfully established. The specificity, accuracy, precision, linearity and robustness are good.