米力农注射液中有关物质研究  

Related substances of milrinone injection

作　　者：张庆森[1,2] 张贵民 郝贵周 赵春杰[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]鲁南制药集团股份有限公司国家手性制药工程技术研究中心,临沂276006

出　　处：《中国药科大学学报》2014年第6期695-697,共3页Journal of China Pharmaceutical University

基　　金：国家火炬计划资助项目(No.2011GH021352)~~

摘　　要：建立用于米力农注射液有关物质测定的HPLC法,为建立米力农注射液质量控制标准提供依据。采用波谱技术对检出主要杂质进行了结构鉴定（其中杂质B的结构为首次鉴定）。色谱柱为Waters Symmetry C18（250 mm×4.6 mm,5μm）,流动相为p H 7.5的磷酸盐缓冲液-甲醇（75∶25）,检测波长为254 nm,流速为1.0 m L/min。在所建立的色谱条件下,米力农与各杂质分离良好;米力农、米力农杂质A和米力农杂质B在0.05~3.2μg/m L范围内,线性关系均良好;米力农、杂质A和杂质B的最低检测限均为0.017μg/m L。结果表明,所建立的方法简便、灵敏、专属性强,可用于米力农注射液有关物质的测定。The aim of the current study was to establish an HPLC method for the determination of related substances of milrinone injection,and identify the structures of the main impurities by spectral techniques. The structural identification of impurity B was done for the first time. The separation was performed on a Waters Symmetry C18 column（ 250 mm × 4. 6 mm,5 μm）,and the mobile phase was phosphate buffer-methanol（ 75 ∶ 25）. The detection wavelength was 254 nm,and the flow rate was 1. 0 m L / min. Milrinone and its related substances were separated,and the calibration curves were linear over the concentration ranges of 0. 05-3. 2 μg / m L（ r = 0. 999 5） for milrinone,0. 05-3. 2 μg / m L（ r = 0. 999 8） for milrinone impurity A,and 0. 05-3. 2 μg / m L（ r = 0. 999 4） for milrinone impurity B,respectively. The LOD values of milrinone,milrinone impurity A and milrinone impurity B were all 0. 017 μg / m L.This method is simple,sensitive and specific. It is suitable for the quality control of milrinone injection.

关 键 词：米力农注射液 有关物质 杂质A 杂质B 结构鉴定 HPLC 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]