RP-HPLC测定桂利嗪分散片的含量及检查有关物质  

Determination of cinnarizine content and its related substances in Cinnarizine dispersible tablets by RP-HPLC

作　　者：刘魁[1] 戎欣玉[2] 刘海波[2] 王云清[1] 李子成[1] 

机构地区：[1]河北科技大学理学院,河北石家庄050018 [2]河北科技大学化学与制药工程学院,河北石家庄050018

出　　处：《华西药学杂志》2008年第2期227-228,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法测定桂利嗪分散片的含量及有关物质。方法用Kromasil C18色谱柱(250 mm×4.6 mm,5μm);流动相为甲醇-0.2%三乙醇胺-三乙胺(85:15:0.03,盐酸调pH6.5);流速1.0 ml.min-1;检测波长254 nm;柱温为室温。结果桂利嗪的线性范围为20~200μg.ml-1(r=0.9999),最低检测限为0.2 ng.ml-1;样品溶液至少在8 h内稳定,回收率99.4%,RSD=0.92%(n=9)。结论所建方法简便、快速,专属性好,可用于桂利嗪分散片的含量测定和有关物质检查。OBJECTIVE To establish a method for determination of content and related substances in cinnarizine dispersible tablets.METHODSRP-HPLC was adopted.The column was Kromasil C18(250 mm×4.6 mm,5 μm)with the mobile phase consisted of methanol-0.2% triethanol amine-triethylamine(85:15:0.03,adjusted pH6.0 with 3 mol·L-1HCl).The flow rate was 1.0 ml·min-1with the UV detector set at 254 nm.RESULTSThe linear range of the determination was 20～200 μg·ml-1with the correlation coefficient of 0.9999,and lowest detectable l...

关 键 词：桂利嗪 分散片 含量 有关物质 高效液相色谱法 

分 类 号：R927[医药卫生—药学]