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.
出处
《中国药师》
CAS
2012年第10期1450-1452,共3页
China Pharmacist