奥拉西坦残留溶剂的测定  

Determination of residual solvents in oxiracetam

作　　者：王晔 WANG Ye(Anhui Institute for Food and Drug Control,Hefei 230051,China)

机构地区：[1]安徽省食品药品检验研究院,合肥230051

出　　处：《中国药品标准》2022年第5期525-528,共4页Drug Standards of China

摘　　要：目的:建立奥拉西坦原料药中甲醇、乙醇、二氯甲烷、正己烷、环己烷、甲苯、二甲苯和苯八类残留溶剂的测定方法。方法:采用毛细管柱色谱直接进样法,色谱柱DB-624型毛细管柱,柱温采用程序升温,检测器为氢火焰离子化检测器,载气为氮气,柱流量为1.0 mL·min^(-1)。结果:8种溶剂均获得基线分离,浓度范围内与峰面积线性关系良好,每个残留溶剂组分平均回收率均符合要求。测定样品3批,甲醇含量均为0.01%,其他七种残留溶剂均未检出。结论:本法专属性强、重复性好、结果可靠、适用于奥拉西坦原料药中残留溶剂的测定。Objective:To establish a method for the determination of residual solvents in methanol,ethanol,dichloromethane,n-hexane,cyclohexane,toluene,xylene and benzene in oxiracetam raw materials.Methods:Using capillary column chromatography direct injection method,chromatographic column DB-624 capillary column,the column temperature adopts programmed temperature rise,the detector was a hydrogen flame ionization detector,the carrier gas was nitrogen,and the column flow rate was 1.0 mL·min^(-1).Results:Baseline separation was obtained for all 8 solvents,and the linear relationship with peak area was good within the concentration range,and the average recovery rate of each residual solvent component met the requirements.Three batches of samples were tested,the methanol content was 0.01%,and the other seven residual solvents were not detected.Conclusion:This method has strong specificity,good repeatability and reliable results,and is suitable for the determination of residual solvents in oxiracetam raw materials.

关 键 词：奥拉西坦 羟基氨基酸丁酸环状衍生物 神经病变 磷酰乙醇胺 磷酰胆碱 残留溶剂 

分 类 号：R921.2[医药卫生—药学]