HPLC法测定盐酸洛贝林注射液中的有关物质  

Determination of Related Substances in Lobeline Hydrochloride Injection by RP-HPLC

作　　者：夏瑞[1] 代红[1] 车宝泉[1] 张喆[1] 郭洪祝[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药品标准》2009年第1期46-50,共5页Drug Standards of China

摘　　要：目的:采用反相高效液相色谱法测定盐酸洛贝林注射液中的有关物质。方法:采用反相高效液相色谱法,C18柱,流动相为0.05mol·L-1磷酸二氢钾溶液(用磷酸调节pH值至3.0)-甲醇(55∶45)为流动相;检测波长为210nm。结果:盐酸洛贝林注射液中除主峰(顺式洛贝林)外,出现一较大含量的色谱峰,为洛贝林的异构体(反式洛贝林);盐酸洛贝林与其他杂质分离良好,样品溶液在8h内稳定;结论:所建方法能有效地分离盐酸洛贝林注射液中的有关物质,方法简单、可靠。Objective ：To develop a method for determination of related substance in Lobeline Hydrochloride Injection by RP-HPLC. Method：The analysis was performed on a C18 column, using mobile phase consisted of 0. 05mol/L potassium dihydrogen phosphate solution （adjusted to pH 3.0 with phosphoric acid）-methanol （55：45 ）. The detection wavelength was 210 nm. Results：There were a big content chromatograph peak of trans-（ - ）-Lobeline and the prominent peak which is cis-（ - ）-Lobeline in Lobeline Hydrochloride Injection. Lobeline Hydrochloride and related substances could he separated well. Samples were stable in 8 hrs. Conclusion：This meth- od can be used to simultaneously separate and determine the related substances in Lobeline Hydrochloride Injection. It is simple and accurate.

关 键 词：盐酸洛贝林 高效液相色谱法 有关物质 

分 类 号：R593.1[医药卫生—内科学] R971[医药卫生—临床医学]