盐酸氯环利嗪有关物质的测定  

Determination of Related Substances in Chlorcyclizine Hydrochloride

作　　者：杨本霞[1] 郑子栋[1] 赵用强 

机构地区：[1]河南省食品药品检验所,河南郑州450003 [2]焦作福瑞堂制药有限公司,河南焦作414500

出　　处：《中国医药工业杂志》2015年第1期62-64,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法配合气相色谱法测定盐酸氯环利嗪的有关物质。采用GC法测定已知有关物质N-甲基哌嗪。使用Rtx-1毛细管色谱柱，程序升温，氢火焰离子化检测器。N-甲基哌嗪在10～100μg／ml浓度范围内线性关系良好，平均回收率为99．3％，RSD为1.3％，最低检测限为0．22μg／ml。采用HPLC法测定其他未知有关物质。使用C18色谱柱，以乙腈：0．01mol／L磷酸二氢钾溶液（含0．4％三乙胺，用磷酸调至pH3．5）（35：65）为流动相，检测波长231nm，盐酸氯环利嗪与降解产物能有效分离。An HPLC method combined with a GC method was established for the determination of the related substances in chlorcyclizine hydrochloride. N-Methylpiperazine, a known related substance in chlorcyclizine hydrochloride, was determined by GC. A Rtx- 1 capillary column was used with the application of temperature program and flame ionization detector. It was linear for N-methylpiperazine in the range of 10 - 100 μg/ml. The average recovery was 99.3 %, with RSD of 1.3 %. Its low limit of detection was 0.22 μg/ml. Other unknown related substances were determined by HPLC. A C18 columrl was used, with the mobile phase of acetonitrile ： 0.01 mol/L potassium dihydrogen phosphate solution （containing 0.4% triethylamine, adjusted with phosphoric acid to pH 3.5） （35 ： 65） at the detection wavelength of 231 nm. Chlorcyclizine hydrochloride could be separated well with its degradation products. Key Word： chlorcyclizine hydrochloride; related substance; N-methyl piperazine; HPLC; GC; determination

关 键 词：盐酸氯环利嗪 有关物质 N-甲基哌嗪 高效液相色谱 气相色谱 测定 

分 类 号：O657.71[理学—分析化学] O657.72[理学—化学]