摘要
目的建立马来酸桂哌齐特中4种有机残留溶剂的测定方法。方法采用毛细管气相色谱法对马来酸桂哌齐特中环己烷、二氯甲烷、乙醇和甲苯的残留量进行测定。色谱柱:PEG-20M毛细管(30 m×0.25 mm×0.25μm)柱;进样口温度:200℃,FID检测器温度:250℃,初始柱温为40℃,保持6 min,以10℃/min升到60℃,保持1 min,再以50℃/min升到220℃,保持2 min;载气为氮气,甲醇为内标物。结果环己烷、二氯甲烷、乙醇和甲苯均能得到有效分离,其峰面积与质量浓度均呈良好的线性关系,平均回收率为97.4%～103.8%。结论该方法简便、准确、灵敏度高,可用于马来酸桂哌齐特中有机残留溶剂的检测。
Objective To develop a capillary gas chromatography method for the determination of 4 kinds of residual organic solvents in cinepazide maleate.Methods Residual organic solvents（cyclohexane,dichlormethane,ethonal and methyl benzene）in cinepazide maleate were separated by PEG-20M capillary column（30 m×0.25 mm×0.25 μm） with a FID detector.The injector temperature and the detector temperature were controlled at 200 ℃ and 250 ℃,respectively.The column temperature program was as follows： initial temperature 40 ℃（hold for 6 min）,with the increasing rate of 10 ℃/min to 60 ℃（hold for 1 min）,50 ℃/min to 220 ℃（hold for 2 min）.The assay of residual solvents was calculated by internal standard method.The internal standard substance was methanol.Results The residual solvents（cyclohexane,dichlormethane,ethonal and methyl benzene）were separated completely.The calibration curve of each solvent showed good linear relationship.The average recovery ratios were between 97.4%-103.8%.Conclusion The method is simple,accurate and reliable,which can be used for the determination of the residual organic solvents in cinepazide maleate.
出处
《广东药学院学报》
CAS
2011年第5期499-501,共3页
Academic Journal of Guangdong College of Pharmacy
