RP-HPLC测定盐酸西布曲明中的有关物质  

Determination of related substances in sibutramine hydrochloride by RP-HPLC

作　　者：郑萍[1] 朱兰[2] 罗霞 李章万[1] 

机构地区：[1]四川大学华西药学院,四川成都610021 [2]四川大学华西医院,四川成都610041 [3]成都市药品检验所,四川成都610061

出　　处：《华西药学杂志》2005年第2期168-170,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的　建立盐酸西布曲明原料中有关物质的检查方法。方法　色谱柱为HPODShypersil (5 μm ,12. 5mm×4mm) ,流动相为甲醇-水-三乙胺(85∶15∶0 . 0 1) (含0 .0 0 1mol·L-1庚烷磺酸钠,醋酸调pH 7.8) ,检测波长2 2 2nm ,流速1.0ml·L-1。结果　合成反应中的两个重要中间体与破坏产生的降解产物均能有效地分离,中间体的最低检出量为0 .1ng,控制总杂质量不得过2 .0 %。结论　该方法简便、准确、有效。OBJECTIVE To establish a method for the determination of related substances in sibutramine hydrochloride.METHODS RP-HPLC method was adopted.The column was HP ODS hypersil (5 μm,125 mm×4 mm),and mobile phase consisted of methanol-water-triethylamine (85∶15∶0.01)[(containing 0.001 mol·L -1 sodium heptanesulfonate )adjusted to pH 7.8 with acetic acid]. The detective wavelength was 222 nm with a flow rate of 1.0 ml·min -1.RESULTS A satisfactory separation among two related impurities was obtained and the LOD of intermediate was 0.1 ng.CONCLUSION The method was simple,accrate and available.

关 键 词：RP-HPLC 西布曲明 有关物质 色谱系统 

分 类 号：R927.2[医药卫生—药学]