毛细管气相色谱法测定多潘立酮中9种有机溶剂的残留量

Determination of nine residual organic solvents in Domperidone by capillary gas chromatography

目的提出了顶空毛细管气相色谱法测定多潘立酮中甲醇、乙醇、二氯甲烷、四氢呋喃、甲基异丁基酮、N,N-二甲基甲酰胺、甲苯和二甲苯的残留量与直接进样毛细管气相色谱法测定三氯甲烷的残留量。方法 8种溶剂测定法：以DB-1毛细管柱为色谱柱,FID检测器,采用程序升温;三氯甲烷测定法：以DB-624毛细管柱为色谱柱,ECD检测器,采用程序升温。结果定量测定的9种有机溶剂峰面积与进样浓度呈良好线性关系,相关系数均大于0.999 0;加标回收率在91.09%-104.44%之间。结论本法准确、快速,可用于多潘立酮9个有机溶剂残留量的质量控制。

Objective A headspace capillary gas chromatography method was proposed for determination of residual organic solvents methanol,ethanol,dichloromethane,tetrahydrofuran,methyl isobutyl ketone,N,N-dimethylformamide,toluene,xylene in Domperidone and a capillary gas chromatography method was proposed for determination of residual organic solvents chloroform in Domperidone.Methods Determination of eight organic solvents：DB-1 capillary column was used with temperature of programmed control,FID detector was adopted in the determination;Determination of chloroform：DB-624 capillary column was used with temperature of programmed control,ECD detector was adopted in the determination.Results The content of nine solvents showed good linearityin a detected concentration rang（r0.999 0）,the average were ranged from 91.09%~104.4%.Conclusion The method was accurate and rapid,and can be used for the quality control of residual organic solvents methanol in Domperidone.