摘要
目的 :建立了盐酸西布曲明原料中的有关物质的检测和控制方法。方法 :高效液相色谱法 ,YWGC1 8色谱柱 (4 .6 m m×2 5 0 mm ,10μm) ,流动相 :甲醇 -水 -三乙胺 [(80∶ 2 0∶ 0 .1) ,用冰醋酸调节 p H值 =7]检测波长 2 2 3nm ,流速 1.0 ml.min- 1 。结果 :合成反应中二个重要中间体 ,能够得到有效分离 ,最低检出量为 1ng,控制总杂质量不得超过 1.0 %。结论 :本方法准确、有效。
OBJECTIVE:To establish a method for the control of related substances in Sibutramine hydrochloride, monohydrate. METHOD:A HPLC method was developed. Chromatographic conditions included a YWG C 18 Column with the mobile phase of methanol Water trithylamine(80:20:0.1,adjusting pH to 7.0 with glacial acetic acid).The UV detection wavelength was set at 223nm. RESULTS:A satisfactory separation among two related impurities and the sample was obtained. The LOD is 1ng.CONCLUSION:the total impurities is not more than 1.0%,This method could be used for the impurity control. It is simple,quick and precise.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2001年第4期299-301,共3页
Chinese Journal of Modern Applied Pharmacy
