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目的建立HPLC法测定盐酸胺碘酮及其有关物质的含量。方法采用Dikma Diamonsil C18柱(150 mm×4.6mm,5μm),流动相为乙腈-甲醇-水(33∶30∶37)等度洗脱,紫外检测波长240 nm,流速1.0 m L·min-1。结果盐酸胺碘酮在3.0~180.0 mg·L-1内具有良好的线性关系(r=1),最低检测限为0.02 mg·L-1,样品溶液在12 h内稳定,精密度良好(RSD<2.2%),回收率为98.0%~103.2%,2批样品的标示百分含量分别为98.07%和98.60%,5批样品的有关物质的含量分别为0.377 2%、0.319 6%、0.449 4%、0.176 7%和0.424 7%。结论本方法快速、简便、灵敏,结果可靠准确,可用于盐酸胺碘酮及其有关物质的含量测定。
Objective To establish an HPLC method for the determination of amiodarone hydrochloride and its related substances. Methods Dikma Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase was isocratic elution was acetonitrile-methanol-water (33:30:37). The detection wavelength was 240 nm and the flow rate was 1.0 m L · min -1 . Results Amiodarone hydrochloride had good linearity (r = 1) in the range of 3.0-180.0 mg · L-1 and the lowest detection limit was 0.02 mg · L-1. The sample solution was stable within 12 h with good precision (RSD <2.2%). The recoveries ranged from 98.0% to 103.2%. The labeled contents of two batches of samples were 98.07% and 98.60% respectively. The contents of related substances in five batches of samples were 0.377 2%, 0.319 6% and 0.449 4, respectively %, 0.176 7% and 0.424 7%. Conclusion The method is rapid, simple and sensitive, and the results are reliable and accurate. It can be used for the determination of amiodarone hydrochloride and its related substances.