HPLC法检查氟马西尼的有关物质

Determination of Related Substances in Flumazenil by HPLC

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.