HPLC法测定阿米三嗪萝巴新片的有关物质

Determination of Almitrine and Raubasine Tablets by HPLC

目的：采用HPLC法测定阿米三嗪萝巴新片的有关物质.方法：采用C18（4.6 mm×250 mm,5μm）色谱柱,流动相为甲醇∶水=85∶15（每1000 mL含二乙胺5μL）;流速为1.5 mL/min,检测波长为222 nm.结果：阿米三嗪及萝巴新的线性范围分别为0.15～4.5 μg/mL、0.05～1.5 μg/mL;平均回收率分别为100.6％、99.3％;结论：本法简便、准确、适合于阿米三嗪萝巴新片有关物质测定.

Objective： To establish an HPLC method for quantitative determination of Almitrine and Raubasine Tablets. Methods： The analytical column was C 18 （4.6 mm×250 mm, 5 μm） column. The mobile phase was composed of methanol and water=（85 ： 15）（5 μL diethylamine/1000 mL） at a flow rate of 1.5 mL/min. The wavelength of UV detector was 222 nm. Results： The linear ranges of Almitrine were 0.6-360 μg, Raubasine were 0.2- 120 μg, respectively. The contents of Almitrine and Raubasine were 100.6 %, 99.3 %. Conclusion： This method is sensitive, repeatable to determine the content of Almitrine and Raubasine Tablets.