富马酸替诺福韦二吡呋酯中基因毒性杂质溴乙烷的GC-MS/MS法测定

Determination of Bromoethane in Tenofovir Disoproxil Fumarate by GC-MS/MS

建立了气相色谱-串联质谱法测定富马酸替诺福韦二吡呋酯中的基因毒性杂质溴乙烷。样品经DB-5MS毛细管色谱柱分离,采用串联质谱,以多反应监测模式(MRM)检测,溴乙烷在54.01～756.20ng/ml范围内线性关系良好,检测限为14.74 ng/ml,加样回收率为96.7%,RSD为3.43%。本方法可用于富马酸替诺福韦二吡呋酯中溴乙烷杂质的监测。

A GC-MS/MS method was established for the determination of a genotoxic impurity bromoethane in tenofovir disoproxil fumarate.Samples were separated by DB-5MS column,and determined by tandem mass spectrometry in MRM mode.It was linear in the range of 54.01-756.20ng/ml.The limit of determination was 14.74ng/ml.The recovery was 96.7%with RSD of 3.43%.Due to the high specificity,this method could be used to detect bromoethane in tenofovir disoproxil fumarate product.