气相色谱法测定盐酸金刚乙胺中3种有关物质  

Simultaneous Determination of Three Related Substances in Rimantadine Hydrochloride by GC

作　　者：张丽[1] 张迪[1] 黄海[1] 岳青阳[1] 修鸣[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2012年第10期1450-1452,共3页China Pharmacist

摘　　要：目的:采用气相色谱法测定盐酸金刚乙胺中已知有关物质杂质B、杂质A和杂质C的含量。方法:样品经氢氧化钠碱化处理,正己烷提取,以金刚烷为内标物质,采用分流进样法,以RESTEK Rtx-5毛细管色谱柱(30 m×0.32 mm,0.25μm)为分析柱进行分离测定。结果:杂质A在9.996～199.92μg·ml-1范围内具有良好线性关系(r=0.999 6),平均回收率为98.99%(RSD=0.9%,n=9);杂质B在10.02～200.48μg·ml-1范围内具有良好线性关系(r=0.999 2),平均回收率为99.21%(RSD=0.9%,n=9);杂质C在10.14～202.80μg·ml-1范围内具有良好线性关系(r=0.999 5),平均回收率为100.03%(RSD=1.2%,n=9)。结论:本法灵敏度高、结果准确、重复性好,可用于盐酸金刚乙胺有关物质的测定。Objective： To establish a GC method for the determination of three impurities in rimantadine hydrochloride.Method： The solution alkalized by NaOH was extracted by n-hexane,injected by a sample inlet splitter,and then separated by an Rtx-5 capillary column（30 m×0.32 mm,0.25μm）.Result： The linear range of impurity A was 9.996-199.92 mg·ml-1（r=0.999 6）,impurity B was 10.02-200.48 mg·ml-1（r=0.999 2） and impurity C was 10.14-202.80 mg·ml-1（r=0.999 5）.The average recovery was 98.99%（RSD=0.9%,n=9）,99.21%（RSD=0.9%,n=9） and 100.03%（RSD=1.2%,n = 9）,respectively.Conclusion： The method is simple,accurate and reproducible.It can be used in the determination of impurity A,B and C in rimantadine hydrochloride.

关 键 词：盐酸金刚乙胺 有关物质 毛细管气相色谱法 

分 类 号：R927.2[医药卫生—药学]