目的 对吸附白喉-破伤风-无细胞百日咳（组分）联合疫苗〔diphtheria，tetanus and pertussis（acellular，component）vaccine，DTacP〕中表面活性剂Berol 185残留量的液相色谱-串联质谱检测法进行验证。 方法 采用液相色谱-串联质谱法筛选定量离子对，采用外标法对样品中Berol 185定量，并进行方法学验证。 结果 将630.05→89.10作为Berol 185定量离子对；Berol 185浓度在5~120 μg/L范围内线性良好（决定系数＞0.990 0，回收率在80%~120%）；样品重复性相对标准偏差为1.8%~4.2%，中间精密度相对标准偏差为3.0%~3.6%，加标回收率为96.1%~111.9%；不同温度（35、37和40 ℃）或不同检测时间（0、4、8、12、16、20、24 h）样品检测结果稳定。 结论 该方法具有良好的线性、精密度、准确性和耐用性，可用于DTacP中Berol 185的定量检测和工艺过程监测。

Objective To validate the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the detection of Berol 185 residues in diphtheria, tetanus and pertussis (acellular, component) vaccine (DTacP) . Methods LC-MS/MS was used to screen quantitative transitions, external standard method was used to quantify Berol 185 in the samples, and the methodology was verified. Results The quantitative transition of 630.05→89.10 was screened for final quantification. Linearity range was 5-120 μg/L (coefficient of determination>0.990 0, and the recovery rate was 80%-120%). The relative standard deviations (RSDs) of reproducibility were 1.8%-4.2%, the RSD of intermediate precision were 3.0%-3.6%, and the recoveries were 96.1%-111.9%. The results were stable at different temperatures (35, 37 and 40 ℃) or different detection times (0, 4, 8, 12, 16, 20, 24 h). Conclusion The method has good linearity, precision, accuracy and durability, and can be used for quantitative detection and process monitoring of Berol 185 in DTacP.