HPLC法检查氟马西尼的有关物质  

Determination of Related Substances in Flumazenil by HPLC

作　　者：李虎将 李文玉[2] 

机构地区：[1]吉林省通化市疾病预防控制中心,通化134000 [2]通化市食品药品检验所

出　　处：《中国药事》2010年第4期394-396,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立氟马西尼的有关物质检查方法。方法采用HPLC法,色谱柱为极限AQ-C18,以0.1%柠檬酸溶液-乙腈（68∶32）为流动相,流速为0.80mL.min-1,检测波长为230nm,进样量为20μL。结果氟马西尼在0.0032688-4.086μg范围内线性关系良好;样品溶液在11h内稳定（RSD=0.73%）,最低检测限为8pg。结论与《欧州药典》方法比较,本方法简便快速,结果准确可靠,重现性好,可用于氟马西尼的有关物质检查。Objective To establish the method for determination of related substances in flumazenil.Methods HPLC method was used.Column for the limits of AQ-C18,with 0.1% citric acid solution-acetonitrile（68∶32） as mobile phase at flow rate of 0.80mL·min^-1,detection wavelength at 230nm,injection volume for 20μL.Results Flumazenil in the range of 0.0032688～4.086μg had a good linear relationship.The sample solution was stable in 11hrs（RSD=0.73%）.The minimum detection limit was 8pg.Conclusion With the European Pharmacopoeia methods,this method is simple,rapid,accurate,reliable and reproducible.It can be used for determination of related substances in flumazenil.

关 键 词：氟马西尼 有关物质 HPLC 

分 类 号：R927.11[医药卫生—药学]