HPLC法测定盐酸胺碘酮及其有关物质的含量  

Determination of amiodarone hydrochloride and its related substances by HPLC

作　　者：朱嘉俊[1] 吕燕平[1] 郁颖佳[1] 段更利[1] 

机构地区：[1]复旦大学药学院药物分析教研室,上海201203

出　　处：《中国临床药学杂志》2014年第5期296-300,共5页Chinese Journal of Clinical Pharmacy

摘　　要：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（150mm×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240nm，流速1．0mL·min^-1。结果盐酸胺碘酮在3．0～180．0mg·L^-1内具有良好的线性关系（r=1），最低检测限为0．02mg·L^-1，样品溶液在12h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0．3772％、0．3196％、0．4494％、0．1767％和0．4247％。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。AIM To establish a HPLC method for the quality control of amiodarone hydrochloride and its related substances. METHODS The separation was performed on a Dikma Diamonsil C18 column （150 mm × 4.6 mm,5 μm） . The mobile phase consisted of acetonitrile, methanol and water（33：30：37）. The UV detection was set at 240 nm with the flow rate of 1.0 mL· min^-1. RESULTS The assay showed good linear correlation over the range of 3.0 - 180.0 mg· L^-1（ r = 1）. The limit of detection of amiodarone hydrochloride was 0.02 mg·L^-1. The sample solution was stable in 12 h with RSD less than 2.2%. The average recovery of the method was between 98.0% - 103.2%. The content in two batches of samples was 98.07 % and 98.60 %, respectively. The content of related substances in five batches of samples were 0.377 2%, 0.319 6%, 0.449 4%, 0. 176 7% and 0.424 7%, respectively. CONCLUSION This method is rapid, simple, sensitive and accurate with valuable application to the quality control of amiodarone hydrochloride.

关 键 词：盐酸胺碘酮 高效液相色谱法 有关物质 含量测定 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]