论文部分内容阅读
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2.0~50.0mg·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 an RP-HPLC method for the determination of atomoxetine hydrochloride and related substances. Methods: Kromasil C18 column (4.6mm × 250mm, 5μm) was used. The mobile phase consisted of acetonitrile-water-triethylamine (40:60:50, , Detection wavelength: 270nm, column temperature: room temperature. Results: There was a good linear relationship between the substance and the determination of atomoxetine in the range of 2.0-50.0 mg · mL-1 (r = 0.9998) and the average recovery was 99.8% (RSD = 1.7%). , The detection limit was 80μg.L-1 (S / N = 3). Tomoxetine hydrochloride and related substances isolated. Conclusion: The method is simple, reproducible, and specific, and can be used for the determination of atomoxetine hydrochloride and related substances.