GC/MS测定复方氢氧化铝片中增塑剂含量

Analysis of Plasticizer in Compound Aluminum Hydroxide Tablets With GC-MS/MS

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 develop GC/MS method in detect plasticizers in compound aluminum hydroxide tablets adsorbed from pharmaceutical packaging. METHODS The column： HP-5MS silica capillary column （30 m×0.25 μm,0.25 mm） was used; Ion source temperature was 230 ℃; Quadrupole temperature was 150 ℃; The total ion scanning rang： m/z 50～500. RESULTS The diethylhexyl phthafate linearity was in the range of 0.5-20.0 μg·mL-1 with a regression coefficient of 0.999 0. The average recovery of this method was 98.8%, and RSD was 1.4%. The RSD of intra-day and inter-day was 2.8% and 3.7% respectively. CONCLUSION This method is specificity, sensitive, and can be applied to detect and research DEHP which may be adsorbed or penetrated into drugs.