盐酸纳美芬注射液有关物质的HPLC法测定  

Determination of Related Substances in Nalmefene Hydrochloride Injection by HPLC

作　　者：袁辛娅 潘伟 吴理达 杨丽红 

机构地区：[1]成都翰朗生物科技有限公司,四川成都610041

出　　处：《中国医药工业杂志》2010年第3期208-210,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法测定盐酸纳美芬注射液中有关物质盐酸纳曲酮和双纳美芬的含量。采用C18柱,乙腈-0.05mol/L磷酸盐缓冲液(20∶80,含0.2%三乙胺,85%磷酸调至pH4.2)为流动相,检测波长210nm。盐酸纳曲酮和双纳美芬均在0.1～1.5μg/ml浓度范围内,线性关系良好(r均为0.9994)。盐酸纳美芬、盐酸纳曲酮和双纳美芬的检测限分别为0.2、0.4和0.04ng。An HPLC method was established for the determination of related substances, nalterxone hydrochloride and bisnalmefene, in nalmefene hydrochloride injection. A C18 column was used with the mobile phase of acetonitrile-0.05 mol/L phosphate buffer （20 ： 80, containing 0.2 % triethylamine, adjusted to pH 4.2 by 85 % phosphoric acid）, at the detection wavelength of 210 nm. The calibration curves of nalterxone hydrochloride and bisnalmefene were linear in the concentration range of 0.1 - 1.5 μg/ml （r=0.999 4）. The detection limits of nalmefene hydrochloride, nalterxone hydrochloride and bisnalmefene were 0.2, 0.4 and 0.04 ng, respectively.

关 键 词：盐酸纳美芬 盐酸纳曲酮 双纳美芬 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]