盐酸特比萘芬有关物质检查色谱条件与系统适用性的探讨  

Discussion on Chromatographic Condition and System Suitability of Related Substance Examination of Terbinafine Hydrochloride

作　　者：彭敏[1] 

机构地区：[1]江门市药品检验所,广东江门529000

出　　处：《食品与药品》2017年第6期445-447,共3页Food and Drug

摘　　要：目的对2015年版《中国药典》中盐酸特比萘芬有关物质检测色谱条件与系统适用性进行探讨。方法分析检验图谱并查阅国外药典。结果 2015年版《中国药典》中盐酸特比萘芬有关物质检测系统适用性的规定存在问题,有待完善。结论建议修改盐酸特比萘芬有关物质检测系统适用性中的主峰保留时间及杂质峰的相对保留时间。Objective To discuss chromatographic condition and system suitability of related substance examination ofTerbinafine Hydrochloride listed in Chinese Pharmacopoeia （2015 edition）. Methods The results obtained in the process ofinspection were analyzed and the foreign pharmacopoeias were consulted. Results There are problems in chromatographiccondition and system suitability of related substance examination of Terbinafine Hydrochloride listed in ChinesePharmacopoeia （2015 edition） which need to be solved. Conclusion It is suggested that the retention time of terbinafine and relative retention time of the impurities should be amended.

关 键 词：中国药典 盐酸特比萘芬 色谱条件 系统适用性 

分 类 号：R978.5[医药卫生—药品] R927.1[医药卫生—药学]