目的:建立聚氯乙烯(PVC)输液装置中新型增塑剂对苯二甲酸二辛酯(DOTP)的检测方法,为临床安全性提供有效的评价手段。方法:采用液-质联用(LC-MS)法,流动相为0.1%甲酸水溶液-甲醇(5∶95),流速0.3 ml·min-1,进样量10μl,柱温30℃,正离子SIR检测模式。结果:DOTP的保留时间为4.87 min,在0.10~50.00μg·ml-1线性关系良好,重复性RSD为1.6%,溶液48 h稳定,回收率为100.8%。结论:本方法快速准确,适用于PVC输液装置中DOTP溶出量测定。 Objective: To establish a new method for detection of dioctyl phthalate (DOTP) in polyvinyl chloride (PVC) infusion device and to provide an effective evaluation method for clinical safety. Methods: The mobile phase consisted of 0.1% formic acid in methanol (5:95), the flow rate was 0.3 ml · min-1 using liquid chromatography-mass spectrometry (LC-MS) SIR detection mode. Results: The retention time of DOTP was 4.87 min. The linearity of DOTP ranged from 0.10 to 50.00 μg · ml-1 with a reproducible RSD of 1.6%. The solution was stable at 48 h with a recovery of 100.8%. Conclusion: The method is rapid and accurate and suitable for the determination of DOTP dissolution in PVC infusion set.