培美曲塞二钠中亚硫酸二乙酯的GC-MS法测定

Determination of Diethyl Sulfite Inpemetrexed Disodium by GC-MS

建立了气-质联用测定培美曲塞二钠中遗传毒性杂质亚硫酸二乙酯的检测方法,采用 HP-5MS 毛细管色谱柱进行分离,采用GC-MS法以离子监测模式(SIM)进行测定,亚硫酸二乙酯在20~100 ng/ml浓度范围内线性关系良好,定量限为20 ng/ml,回收率101.09%,RSD为3.59%。该法灵敏度、准确度高,可用于培美曲塞二钠中痕量亚硫酸二乙酯的检测。

A GC-MS method was established for determination a genotoxic substance diethyl sulfite in pemetrexed disodium.Samples were separated by HP-5MS column,and determined by mass spectrometry in SIM mode.The diethyl sulfite showed good linearity at the range of 20-100 ng/ml.The limit of determination was 20 ng/ml.The recovery was 101.09%,with RSD of 3.59%.Due to the high specificity,this method could be used to detect diethyl sulfite in pemetrexed disodium product.