RP-HPLC测定盐酸胺碘酮注射液中的有关物质

Determination of Relevant Compounds in Amiodarone Hydrochloride Injection by RP-HPLC

目的:建立RP-HPLC测定盐酸胺碘酮注射液中有关物质的方法。方法:采用十八烷基硅烷键合硅胶色谱柱,2%三乙胺(用磷酸调节pH4.0)-甲醇(20∶80)为流动相,检测波长241nm,流速1.0mL/min,柱温为室温。结果:在5μg/mL^40μg/mL范围内,盐酸胺碘酮浓度与峰面积线性关系良好。结论:该方法操作简便、重现性好、灵敏度高、专属性强,可用于盐酸胺碘酮注射液的质量控制。

Objective：To establish the method of detecting relevant compounds in amiodarone hydrochloride injection by RP-HPLC. Method：RP-HPLC was performed on ODS-2 C18 column （4.6mm×250mm,5μm）with 2% triethylamine： methanol （20：80）as mobile phase at flow rate of 1.0mL/min. The detection wavelength was 241 nm. Result：The liner range of amiodarone hydrochloride injection was 5 μg/mL-40μg/mL. Conclusion ：This method is easy,reproducibility, sensitivity and characteristic, which could be used to control the quality of amiodarone hydrochloride injection.