HPLC法测定匹卡米隆注射液的含量和有关物质  

Determination of the content and the related substances of Picamilon Injection by HPLC

作　　者：孙红英 韩静 

机构地区：[1]山东省医药工业研究所,山东济南250100 [2]北京同仁堂天然药物有限公司,北京100176

出　　处：《齐鲁药事》2008年第2期90-91,共2页qilu pharmaceutical affairs

摘　　要：目的建立高效液相色谱法测定匹卡米隆注射液的含量和有关物质。方法采用C18色谱柱（4．6mm×250mm，5μm），流动相为甲醇-0．03mol·L^-1磷酸氢二钾（15：85）（磷酸调pH7．0），流速1．0mL·min^-1，检测波长为262nm。结果匹卡米隆浓度在20～180mg·L^-1的范围内峰面积与进样浓度呈良好线性关系，r=0．9998；平均回收率为98．9％，RSD=0．74％（n=9）最低检出限为0．2μg·mL^-1。结论本方法简便、准确，专属性强。OBJECTIVE To establish a RP-HPLC method to determine the content and the related substances of Picamilon Injection. METHODS The chromatographic analysis was performed on a C：8 column （4.6min×250mm,5μm）. The mobile . phase consisted of methanol-0.03mol · L^-1 potassium phosphate dibasic（15 ： 85） （adjusted pH to 7.0 with phosphoric acid ）. The flow rate was 1.0mL · min^-1. The detection wavelength was 262nm. RESULTS The calibration curve was linear in the range of 20- 180mg · L^-1 ;The average recovery was 98.9%, RSD was 0. 74% （n =9）. The detection limit was 0. 2μg· mL^-1. CONCLUSION The method wss simple,accurate and specific.

关 键 词：高效液相色谱法 匹卡米隆 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]