论文部分内容阅读
目的建立分析测定复方氢氧化铝片对药品包装中增塑剂吸附情况研究的气质联用方法。方法色谱柱为HP-5MS石英毛细管柱(30 m×0.25μm,0.25 mm);离子源温度230℃,四级杆温度150℃;总离子扫描范围:m/z 50~500。结果邻苯二甲酸二(2-乙基己基)酯(DEHP)的线性浓度范围为0.5~20.0μg.mL-1,r=0.999 0,最低检出浓度为0.016μg.mL-1;回收率为98.8%,RSD为1.4%;日内和日间精密度的RSD分别为2.8%,3.7%。结论该方法专属性强,灵敏度高,适用于药品中可能吸附或渗透的DEHP的检测及研究。
OBJECTIVE To establish a gas chromatography-mass spectrometry (GC-MS / MS) method for the analysis of plasticizer adsorption in pharmaceutical packaging by the analysis of compound aluminum hydroxide tablets. Methods The chromatographic column was HP-5MS quartz capillary column (30 m × 0.25 μm, 0.25 mm). The ion source temperature was 230 ℃ and the temperature of the quadrupole rod was 150 ℃. The total ion scan range was m / z 50-500. Results The linear range of DEHP was 0.5 ~ 20.0μg.mL-1, r = 0.999 0 and the lowest detection limit was 0.016μg.mL-1. The recovery rate Was 98.8% with a RSD of 1.4%. The intra-day and inter-day RSDs were 2.8% and 3.7%, respectively. Conclusion The method is highly specific and sensitive and suitable for the detection and study of DEHP that may be adsorbed or infiltrated in medicines.