高效液相色谱法测定钆贝葡胺注射液中葡甲胺含量的研究

Study on Methodology for Determination of Meglumine in Gadobenate Dimeglumine Injection by HPLC

目的：建立钆贝葡胺注射液中葡甲胺含量测定方法。方法：采用高效液相色谱法，以用Aglient Zorbax 300SCX色谱柱，以三氟乙酸-甲酸-水（0．05：0.3：100）为流动相：柱温为35℃。流速为1．0mL／min。结果：含量测定方法学研究表明，该方法专属性好：钆贝葡胺注射液中葡甲胺在41．27-412．68μg／mL的浓度范围内与其峰响应值呈良好的线性关系，平均回收率为99．7％（RSD=1．1％）。结论：本方法测定结果准确，精密度高，耐用性良好．可以作为钆贝葡胺注射液中葡甲胺的含量测定方法。

Objective： To establish the method for determination of Meglumine in Gadobenate Dimeglumine Injection. Method： The assay involved an isocratic elution of Meglumine in a Agilent Zorbax 300 SCX column, using a mobile phase composition of trifluoroacetic acid and formic acid and water （0.05 ： 0.3 ： 100）, column temperature was 35℃ and the flow rate was 1.0 mL/min. Result： After the Study on methodology for determination, It Indicated that the specificity of method was good; and Meglumine had a good linear range of 41.27-412.68 μg/mL with a mean recovery of 99.7 % （RSD=1.1%）. Conclusion： The assay showed an accurate result, high precision and good durability, which can used as a method for determination of Meglumine in Gadobenate Dimeglumine Injection.