盐酸安非他酮缓释片中的有关物质研究  

Impurities in bupropion hydrochloride sustained-release tablets

作　　者：成舒乔[1] 蔡梅[2] 陈民辉[2] 王玉[1,2] 

机构地区：[1]中国药科大学,南京210009 [2]江苏省食品药品检验所,南京210008

出　　处：《中南药学》2013年第2期89-92,共4页Central South Pharmacy

摘　　要：目的建立同时测定盐酸安非他酮缓释片中3种杂质的反相HPLC方法,并对未知杂质进行定性研究。方法采用Agelar Venusil MP C18(4.6 mm×150 mm,5μm)色谱柱,以乙腈-三氟乙酸-水(10:0.04:90)为流动相A,乙腈-三氟乙酸-水(95:0.03:5)为流动相B,梯度洗脱,检测波长226 nm,对已知杂质进行定性、定量分析。未知杂质用制备液相色谱纯化,再采集质谱和核磁共振谱的数据,用于结构确定。结果在选定的色谱条件下,盐酸安非他酮与各杂质峰均能良好的分离,方法学考察符合分析检测要求。根据质谱和核磁共振谱数据,对分离提纯的未知杂质进行结构确认。结论建立的方法简便、灵敏,专属性好,可同时测定盐酸安非他酮缓释片中3种杂质,对未知杂质结构的确定,为盐酸安非他酮的质量研究提供了依据。Objective To establish a reversed-phase HPLC method for the determination of 3 impurities in bupropion hydrochloride sustained-release tablets, and determine the structure of an unknown impurity. Methods The separation of known impurities was performed on an Agelar Venusil MP Cl8 （4.6 mm× 150 ram, 5 μm） column. The mobile phase A consisted of aeetonitrile - trifluoroacetic acid-water （10 ： 0.04 ： 90）, the mobile phase B consisted of acetonitrile - tri- fluoroacetic acid-water （95 ： 0.03 ： 5）, and the detection wavelength was 226 nm. Preparative liquid chromatograph was used to obtain pure unknown impurity, and figure out its structure through LC/MS and NMR. Results Bupropion hydrochloride and 3 impurities were well separated under selected liquid chromatographic system. The methodological study conformed to the requirements for analysis. Conclusion The study provides the basis for the analysis and study of the impurities in bupropion hydrochloride.

关 键 词：盐酸安非他酮 有关物质 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学] R944.2[医药卫生—药学]