摘要
目的：建立RP-HPLC法测定盐酸托莫西汀的含量和有关物质。方法：采用Kromasil C18（4.6mm×250mm,5μm）色谱柱,流动相：乙腈-水-三乙胺溶液（40：60：0.5,冰醋酸调pH至6.0）,流速：1.0mL·min-1,检测波长：270nm,柱温：室温。结果：有关物质与盐酸托莫西汀分离良好,盐酸托莫西汀在2.050.0mg·mL-1范围内线性关系良好（r=0.9998）,平均回收率为99.8%（RSD=1.7%）,检测限为80μg.L-1（S/N=3）。盐酸托莫西汀与有关物质分离良好。结论：该方法操作简便、重复性好、专属性强,可用于测定盐酸托莫西汀的含量和有关物质。
Objective：To establish a HPLC method for determination the content of atomoxetine hydrochloride and its related substances.Methods：The determination of atomoxetine hydrochloride and the separation of its related substances was performed on a Kromasil C18 column（4.6 mm × 250 mm,5 μm）.The mobile phase consisted of acetonitrile-water-triethylamine（40：60：0.5,adjusted pH to 6.0 with acetic acid）.The flow rate was 1.0 mL·min-1.Ultraviolet absorption detector was set at 270 nm and column temperature at room temperature.Results：The linearity of atomoxetine hydrochloride was in the range of 2.0 to 50.0 mg·L-1（r= 0.999 8）.The average recovery was 99.8 % with RSD of 1.7 %.The related substances of atomoxetine hydrochloride were completely separated from atomoxe-tine hydrochloride.The limit of detection（LOD）was 80 μg·L-1（S/N=3）.Conclusions：A reproducible and specific method is provided for the determination of atomoxetine hydrochloride and its related substances
出处
《现代生物医学进展》
CAS
2010年第18期3541-3543,共3页
Progress in Modern Biomedicine
关键词
盐酸托莫西汀
高效液相色谱法
含量测定
有关物质
Atomoxetine Hydrochloride HPLC Quantitative determination Related substances
