HPLC同时测定盐酸曲唑酮中的7种有关物质  

Simultaneous determination of seven related substances of Trazodone hydrochloride by HPLC

作　　者：邹国芳[1] 闫鹏 孙玉静[3] 耿颖姝 薛昊[3] 李巍[4] 

机构地区：[1]深圳市第二人民医院药剂科,广东深圳518035 [2]深圳市泛谷药业有限公司,广东深圳518057 [3]沈阳华泰药物研究有限公司,辽宁沈阳110015 [4]深圳市第三人民医院药剂科,广东深圳518112

出　　处：《华西药学杂志》2014年第4期452-454,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法同时测定盐酸曲唑酮中的7种有关物质。方法采用TopsilTMC18色谱柱(250 mm×4.6 mm,5μm),流动相为二乙胺-乙腈-水(0.4∶57∶43),检测波长254 nm,流速1.5 mL·min-1。结果各有关物质的色谱峰与盐酸曲唑酮的主峰完全分离,盐酸曲唑酮的线性范围为0.5～10.0μg·mL-1,方法的重复性的RSD=7.50%。结论所用方法灵敏、简单、重复性好,可用于盐酸曲唑酮相关物质的检测。OBJECTIVE To establish an HPLC method for the simultaneous determination of seven related substances in Trazodone hydrochloride. METHODS TopsilTM Cls column （250 mm×4.6 mm, 5 μm）was adopted in HPLC system, and diethylamine - acetoni- trile- water（0.4 ： 57 ： 43）was used as mobile phase. The detection wavelength was 254 nm and the flow rate was 1.5 mL· min^-1. RESULTS An excellent separation was achieved for Trazodone hydrochloride and seven related substances. The linear range of Traz- odone bydroehloride was 0.5 - 10.0 μg· mL ^- 1. The repeatability RSD was 7.50%. CONCLUSION The method is sensitive, simple, with a good repeatability and can be used for determination of related substances of Trazodone hydrochloride.

关 键 词：高效液相色谱法 盐酸曲唑酮 有关物质 

分 类 号：R917[医药卫生—药物分析学]