CAJ | 학술논문

目的：建立顶空气相色谱法测定左乙拉西坦中有机溶剂残留量。方法：采用Agilent DB-624毛细管柱（30m×0.53mm，3.0？m）；氮气为载气；进样口温度为220℃；检测器温度为250℃；毛细管柱温度为40℃。顶空进样，平衡温度为85℃，平衡时间为20min；以DMF为溶剂。结果：在本文色谱条件下，各残留溶剂均能得到良好的分离度，检测浓度在所考察的范围内与峰面积具有良好的线性，r=0.9990～0.9999；平均回收率为97.1%~102.5%，精密度试验及准确度试验的RSD均小于3.5%。结论：本试验建立的色谱方法简便、准确，灵敏度高，适合左乙拉西坦有机溶剂残留量的检测。
목적：건립정공기상색보법측정좌을랍서탄중유궤용제잔류량。방법：채용Agilent DB-624모세관주（30m×0.53mm，3.0？m）；담기위재기；진양구온도위220℃；검측기온도위250℃；모세관주온도위40℃。정공진양，평형온도위85℃，평형시간위20min；이DMF위용제。결과：재본문색보조건하，각잔류용제균능득도량호적분리도，검측농도재소고찰적범위내여봉면적구유량호적선성，r=0.9990～0.9999；평균회수솔위97.1%~102.5%，정밀도시험급준학도시험적RSD균소우3.5%。결론：본시험건립적색보방법간편、준학，령민도고，괄합좌을랍서탄유궤용제잔류량적검측。
Objective:To establish a method of headspace capillary gas chromatography for the determination of residual solvents in Leve-tiracetam.Methods:The residual solvents in Levetiracetam were separated by Agilent DB-624.The carried gas was nitrogen.The injector temper-ature and the detector temperature were controlled at 220℃ and 250℃ respectively.The column temperature was controlled at 40℃.The DMF was used as solvent.The containers of headspace injector were in equilibrium at 85℃ for 20min.Results:The detected solvents were separated com-pletely .The calibration curve of each solvent showed a good linear relationship (r=0.9991~0.9999)with good precision and accuracy(RSDs were less than 3.5%). The average recovery rate was in the range of 97.1%~102.5%. Conclusion:The established methed is simple,accurate,sensitive, and can be used for the determination of residual solvents in Levetiracetam.