反相高效液相色谱法测定阿立哌唑的有关物质  

Determination of Related Substances of Aripiprazole by RP-HPLC

作　　者：陈亮[1] 王国海[1] 李春明[1] 郑世君[1] 

机构地区：[1]江苏恩华药业股份有限公司技术中心,江苏徐州221007

出　　处：《中国药业》2010年第12期42-43,共2页China Pharmaceuticals

摘　　要：目的建立测定阿立哌唑有关物质的反相高效液相色谱(RP-HPLC)法。方法色谱柱为Hypersil BDS C18柱(250mm×4.6mm,5μm),以甲醇-四氢呋喃-以醋酸调pH至3.0的30mmol/L醋酸钠缓冲液(35:25:40)为流动相,流速为1.0mL/min,检测波长为254nm,柱温为35℃。结果阿立哌唑与合成反应中的3个中间体能够得到有效分离,总杂质不超过0.5%,检测限为0.202ng。结论 RP-HPLC法简单、快速、准确、专属,可用于阿立哌唑有关物质的测定。Objective To establish a RP-HPLC method to determine the related substances in aripiprazole.Methods The separation was performed on the Hypersil BDS C18 column（250 mm × 4.6 mm,5 μm）.The mobile phase consisted of methanol-tetrahydrofuran-30 mmol/L sodium acetate buffer solution adjusted to pH = 3.0 by acetic acid（35：25：40） with the flow rate of 1.0 mL/min.The detection wavelength was at 254 nm.The column temperature was at 35 ℃.Results A satisfactory separation for the three intermediates and the sample was obtained.The total impurities did not exceed 0.5%.The detection limit of aripiprazole was 0.202 ng.Conclusion The method is simple,rapid,accurate and reproducible,which can be used for the determination of related substances of aripiprazole.

关 键 词：阿立哌唑 有关物质 反相高效液相色谱法 

分 类 号：R927.1[医药卫生—药学] R971.41