摘要
目的建立脑芬泰软胶囊溶剂残留的测定方法。方法采用液体进样气相色谱法,通过内标法来测定脑芬泰软胶囊的溶剂残留。结果本方法的系统适应性较好,准确度高;定量限为10ppm,乙酸乙酯的平均回收率为99. 0%,RSD=2. 6%。结论采用气相内标法测定脑芬泰软胶囊中乙酸乙酯溶剂残留准确度好,适用于脑芬泰中溶剂残留的检查。
OBJECTIVE To study a determination method of residual in Naotaifen soft capsule. METHODS Use liquid sample introduction by GC with internal standard method to determine the residual solvent in Naotaifen soft capsule. RESULTS The method has a better adaptation and has high degree accuracy. The limit of quantitative is 10ppm,the average recovery rate of of ethyl acetate is 99% ,RSD =2.6%. CONCLUSION Use the GC and internal standard method to measure the ethyl acetate solvent residue in Naotaifen soft capsule has better accuracy,it' s suitable for residual solvents in Naotaifen soft capsule examination.
作者
陶俊钰
汪海宣
王玮
叶红兵
刘静
TAO Jun-yu;WANG Hai-xuan;WANG Wei;YE Hong-bing;LIU Jing(Anhui Hefei Center for Food and Drug Control,Hefei 230001,China)
出处
《海峡药学》
2018年第9期63-65,共3页
Strait Pharmaceutical Journal
关键词
气相色谱法
脑芬泰软胶囊
乙酸乙酯
内标法
GC
Naofentai soft capsule
Ethyl Acetate
Internal standard method