A simple, rapid, and sensitive gas chromatography-mass spectrometry (GC-MS) method was developed and validated for the simultaneous determination of two fatty acids, methyl hexadecanoate (MH) and methyl stearate (MS), to allow the evaluation of packaging-drug compatibility. The two migrants were quantified in selective ion-monitoring (SIM) mode, with limits of detection (LOD) of 0.0030 μg/mL and 0.0121 μg/mL. Linear calibration curves for MH and MS were obtained in the concentration ranges of 0.1011–5.0570 μg/mL and 0.2015–10.0740 μg/mL, respectively. The developed method was successfully applied to estimate the safety of the injection of recombinant antitumor-antivirus protein (RAAP). The results showed that the possible maximum daily intake was 3.0 ng and 12.1 ng for MH and MS, respectively. As these values were both below the permitted daily exposure, the migrants can be considered as having low safety risk and do not affect the quality of the injection.

开发了一种简单，快速，灵敏的气相色谱-质谱（GC-MS）方法，并验证了该方法可同时测定十六碳酸甲酯（MH）和硬脂酸甲酯（MS）这两种脂肪酸，从而可以评估包装-药物相容性。以选择性离子监测（SIM）模式对这两种迁移物进行定量，检测限（LOD）为0.0030μg/ mL和0.0121μg/ mL。MH和MS的线性校准曲线分别在0.1011–5.0570μg/ mL和0.2015–10.0740μg/ mL的浓度范围内获得。所开发的方法已成功用于评估重组抗肿瘤-抗病毒蛋白（RAAP）注射的安全性。结果表明，MH和MS的最大可能每日摄入量分别为3.0 ng和12.1 ng。