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RP-HPLC法测定盐酸川丁特罗片的有关物质
RP-HPLC determination of related substances in trantinterol hydrochloride tablets
【摘要】 目的:建立 HPLC 方法测定盐酸川丁特罗片的有关物质。方法:样品经萃取处理,采用 RP-HPLC 法测定有关物质。色谱柱为 Diamonsil TM C18(5 μm,4.6 mm×250 mm);流动相为乙腈-三乙胺溶液(取4 mL 三乙胺加水至1000 mL,用磷酸调pH 值至3.5)(20:80)为流动相;检测波长为246 nm。结果:此色谱条件下药物与降解产物能达有效分离。结论:本法简便、准确、可行。
【Abstract】 Objective:To establish a method for the determination of related substances in trantinterol hydrochloride tablets.Methods:An RP-HPLC method was used after extraction.DiamonsilTM column (5 μm,4.6 mm×250 mm) was adopted.The mobile phase was acetonitrile- triethylamine (4 mL triethylamine,add water to 1000 mL, adjusted to pH 3.5 with H3PO4)(20:80);the detection wavelength was set at 246 nm.Results:trantinterol hydro- chloride and its related substances could be separated well.Conclusions:The method appeared to be simple,accu- rate and reproducible.
【Key words】 RP-HPLC; trantinterol hydrochloride tablet; related substances; extraction;
- 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2008年04期
- 【分类号】R927
- 【被引频次】2
- 【下载频次】109