Determination of Residual Solvents in Terbinafine Hydrochloride by Gas Chromatography with Capillary Column
摘 要
应用HP-5毛细管柱(25 m×0.32 mm,0.25 μm)气相色谱法测定了盐酸特比萘芬药物中乙醚、异丙醇、乙酸乙酯、三氯甲烷、四氢呋喃、甲苯、二甲基甲酰胺等6种残留溶剂.经烘干的试样溶于二甲替甲酰胺(DMF)中,试样溶液中的残留溶剂经毛细管柱分离后,以苯为内标物,内标法定量测定.6种残留溶剂具有良好的分离效果,整体回收率在92.7%~101.0%之间,相对标准偏差(n=6)在1.5%~2.8%之间,6种残留溶剂检出限(S/N=3)依次为1.5,2.8,2.5,12.0,1.7,1.6 mg·L-1.
Abstract
Gas chromatography with HP-5 capillary column (25 m×0.32 mm,0.25 μm) was applied to the determination of 6 residual solvents,i.e.ethyl ether,iso-propanol,ethyl acetate,chloroform,tetrahydrofuran and toluene,in the propylene drug,terbinafine hydrochloride.The dried sample was dissolved in dimethyformamide (DMF) and the residual solvents in the DMF solution were separated on the capillary column,and determined with FID detector using benzene as internal standard.Values of recovery of the six solvents,as a whole,were in the range from 92.7% to 101.0%.Values of RSD′s (n=6) found were in the range of 1.5%-2.8%.Detection limits (S/N=3) of 1.5,2.8,2.5,12.0,1.7 and 1.6 mg·L-1 were found for the 6 solvents respectively.
中图分类号 O657.7
所属栏目 工作简报
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收稿日期 2006/10/27
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备注李东刚(1976-),男,辽宁朝阳人,工程师,主要从事色谱分析和标准化研究工作.
引用该论文: LI Dong-gang,SUN Chang-hua,LI Chun-juan,LI Yan. Determination of Residual Solvents in Terbinafine Hydrochloride by Gas Chromatography with Capillary Column[J]. Physical Testing and Chemical Analysis part B:Chemical Analysis, 2008, 44(2): 152~153
李东刚,孙长华,李春娟,李妍. 毛细管柱气相色谱法测定盐酸特比萘芬中残留溶剂[J]. 理化检验-化学分册, 2008, 44(2): 152~153
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参考文献
【1】国家药典委员会.中华人民共和国药典(二部)[M].北京:化学工业出版社,2005:附录54-55.
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