摘要
目的:通过试验确定葛酮通络胶囊中7种溶剂残留的检测方法。方法:采用气相色谱法,顶空进样,以N,N-二甲基甲酰胺(DMF)为溶解介质,色谱柱:DB-1701(30m×0.32mm×0.25μm),检测器:氢火焰离子化检测器。结果:测定的正己烷、苯、甲基环己烷、甲苯、二甲苯、苯乙烯及二乙烯苯7种有机溶剂完全分离,线性关系良好,平均回收率为93.30%~101.76%,RSD<6.0%。结论:本法方便快捷、准确高、专属性强,可有效用于葛酮通络胶囊中溶剂残留的检测。
Objective:To study and establish a method for determination of seven solvent residues in Getongtongluo capsules.Methods:HeadspaceGas chromatography was adopted,and DMF was used as dissolution medium,which the column was DB-1701(30 m×0.32 mm×0.25μm).The carrier gas was nitrogen,and the detector was FID.Results:Seven organic solvents,such as n-hexane,benzene,methylcyclohexane,toluene,xylene,styrene and divinylbenzene,were completely separated with good linear relationship.The average recovery was 93.30%~101.76%,RSD<6.0%.Conclusion:The method is simple,rapid,accurate and specific,and can be effectively used for the determination of solvent residues in Getongtongluo capsules.
作者
牛海军
李晓亮
李光辉
杨小梅
李凯
NIU Hai-jun;LI Xiao-liang;LI Guang-hui;YANG Xiao-mei;LI Kai(Anhui Joyfar Pharmaceutical Research Institute Co.,Ltd.,Anhui Hefei 230088,China;Anhui Joyfar Pharmaceutical Co.,Ltd.,Anhui Bozhou 236800,China)
出处
《中国药物评价》
2021年第5期387-390,共4页
Chinese Journal of Drug Evaluation
基金
安徽省科技重大专项(项目名称:中药保护品种——国家二类新药葛酮通络胶囊全产业链品质提升研究
项目编号:201903a07020007)。
关键词
葛酮通络胶囊
气相色谱法
溶剂残留
Getongtongluo capsule
Gas chromatography(GC)
Solvent residue