盐酸胺碘酮及其分散片中有关物质的HPLC测定  

Determination of Related Substances in Amiodarone Hydrochloride and Its Dispersible Tablets by HPLC

作　　者：吴涛[1] 卢骏[2] 胡建平 冯岩 

机构地区：[1]北京双鹤药业股份有限公司,北京100102 [2]沈阳药科大学药学院,辽宁沈阳110016 [3]张家口市纽迈特医药技术有限责任公司,河北张家口075000

出　　处：《中国医药工业杂志》2005年第11期699-700,共2页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法测定盐酸胺碘酮及其分散片的有关物质。采用C18色谱柱,0.5%磷酸溶液(三乙胺调至pH4.0)-乙腈(45∶55)为流动相,检测波长242nm。盐酸胺碘酮在50～250μg/ml范围内线性关系良好,检测限为20ng/ml。A HPLC method was established for determination of the related substances in amiodarone hydrochloride and its dispersible tablets. A C18 column was used with the mobile phase of 0.5% phosphoric acid solution （adjusted pH to 4.0 with triethylamine）-acetonitrile （45：55）, at the detection wavelength of 242nm. The calibration curve was linear in the range of 50-250μg/ml, the detection limit of amiodarone hydrochloride was 20ng/ml.

关 键 词：盐酸胺碘酮 分散片 有关物质:高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学]