摘要
建立了气相色谱法测定吡仑帕奈原料药中的5种残留溶剂四氢呋喃、乙醇、乙腈、吡啶、N,N-二甲基甲酰胺及有关物质1,3-丙二醇.使用DB-WAX型色谱柱,采用直接进样,以二甲基亚砜为空白溶剂,程序升温.结果显示,上述5种有机溶剂及1,3-丙二醇回收率均在97.65％～112.88％,RSD均小于5.0％.在线性试验中,各分析物的峰面积与其质量浓度线性关系良好,相关系数均大于0.998.
Abstract
A GC method was established for the determination of the five residual organic solvents(tetrahydrofuran,ethanol,acetonitrile,pyridine,N,N-dimethylformamide)and a related substance(1,3-propanediol)in perampanel raw materials.Tetrahydrofuran,ethanol,acetonitrile,pyridine,N,N-dimethylformamide and 1,3-propanediol were quantitatively determined by direct sampling on DB-WAX column,with DMSO as the solvent and temperature programmed control.The above five organic solvents and 1,3-propanediol were completely separated.Their average recoveries were 97.65％-112.88％,with RSDs less than 5.0％.In the linearity test,good linear relationships between peak areas and mass concentrations of the analytes were achieved,and all the correlation coefficients were more than 0.998.
NETL
NSTL
维普
万方数据