HPLC法测定盐酸决奈达隆片的含量及其有关物质  

Determination of Dronedarone Hydrochloride Tablets and the Related Substances by HPLC

作　　者：仲艳[1] 傅小勤[1] 李家春[1] 陈保来[1] 林夏[1] 王振中[1] 毕宇安[1] 萧伟[1] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中国药房》2013年第37期3528-3531,共4页China Pharmacy

摘　　要：目的：建立测定盐酸决奈达隆片含量及有关物质的方法。方法：采用高效液相色谱法。色谱柱为C18,以甲醇-乙腈-磷酸盐缓冲溶液（32∶50∶18）为流动相,流速为1.5 ml/min,检测波长为220 nm,柱温为40℃。结果：决奈达隆与各杂质分离度良好,盐酸决奈达隆检测质量浓度线性范围为5.2~103.0μg/m（lr=0.999 9）,低、中、高质量浓度回收率分别为100.4%、100.6%、100.2%,平均回收率为100.4%,RSD=0.8%（n=3）;杂质A、杂质B、主成分、杂质C、杂质D的检测限分别是0.25、0.25、0.5、1.0、1.0 ng。结论：建立的方法专属性好、操作简便,可用于盐酸决奈达隆片含量及其有关物质的测定。OBJECTIVE： To establish a method for the content determination of Dronedarone hydrochloride tablets and related substances. METHODS： HPLC method was adopted. The determination was performed on C18 column with mobile phase consisted of methanol-acetonitrile-phosphate buffer solution （32 ： 50 ： 18） at the flow rate of 1.5 ml/min. The detection wavelength was set at 220 nm, and the column temperature was 40（2. RESULTS： Dronedarone was well separated from related substance. The linear range of dronedarone hydrochloride were 5.2-103.0 μg/ml （r=0.999 9）. The recovery rates were 100.4%, 100.6% and 100.2% at low, medium and high concentrations, respectively; average recovery was 100.4% （RSD=0.8%, n=3）. The detection limits of impurity A, impurity B, main component, impurity C and impurity D were 0.25 ng, 0.25 ng, 0.5 ng, 1.0 ng, 1.0 ng. CONCLU- SIONS ： The method is specific, convenient and suitable for the content determination of Dronedarone hydrochloride tablets and re- lated substances.

关 键 词：盐酸决奈达隆片 高效液相色谱法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]