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气相色谱法测定枸橼酸莫沙必利中有机溶剂残留量
引用本文:祖金凤. 气相色谱法测定枸橼酸莫沙必利中有机溶剂残留量[J]. 齐鲁药事, 2011, 30(9): 519-520
作者姓名:祖金凤
作者单位:鲁南贝特制药有限公司,山东,临沂,276006
摘    要:目的建立气相色谱法测定枸橼酸莫沙必利中有机残留量的方法.方法采用气相色谱法,FID检测器,毛细管色谱柱DB-WAX(30m×0.53 mm,0.5μm),程序升温,载气为氮气,进样口温度200℃,检测器温度260℃,以二甲基亚砜为溶剂配制对照溶液及供试品溶液.结果四种有机溶剂完全分离,在所考察的浓度范围内具有良好的线性,甲醇、乙醇、二氯甲烷、三氯甲烷的检测限分别为3.32,4.15,3.19,3.05μg·mL-1,精密度RSD均小于2.5%.平均回收率为98%~104%.结论经方法学验证,本检测方法简便灵敏,结果准确可靠,适用于枸橼酸莫沙必利原料药中有机溶剂残留量的检测.

关 键 词:枸橼酸莫沙必利  有机溶剂残留量  气相色谱法

Determination of residual solvents in Mosapride Citrate by GC
ZU Jin-feng. Determination of residual solvents in Mosapride Citrate by GC[J]. qilu pharmaceutical affairs, 2011, 30(9): 519-520
Authors:ZU Jin-feng
Affiliation:ZU Jin-feng(Lunan Better Pharmaceutical Co.,Ltd.,Linyi 276006,China)
Abstract:Obiective To establish a method for the determination of residual solvents in Mosapride Citrate by GC.Methods The detector was FID.The analytical column was DB-WAX(30 m×0.53 mm,0.5 μm).The injector temperature was 200 ℃,and the detector temperature was 260 ℃.The column temperature was programmed raised.Nitrogen as the carrier gas and the dimethylsulfoxide(DMSO) as solvent media.Results It had a good linearity in the experimental concentration.The detection limit of methanol,ethanol,dichloromethane,trichloromethane separately were 3.32,4.15,3.19,3.05 μg·mL-1.The RSD of precision were all less than 2.5%.The average recovery was 98%~104%.Conclusion this method was simple,sensitive,accurate,and can be used for the detection of four residual solvents in Mosapride Citrate.
Keywords:Mosapride Citrate  Residual solvent  gas chromatography  
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