高效液相色谱法测定盖世龙片中马来酸伊索拉定的含量

Determination of Irsogladine Maleate in Gaslon^N Tablets by HPLC

目的 :运用高效液相色谱法测定马来酸伊索拉定的含量。方法 :以甲醇作溶剂 ,选用LiChrospher 10 0RP - 18e(5 μm)为色谱柱 ,乙腈 -水 -冰醋酸 (2 5 0 :75 0 :3)为流动相 ,检测波长为 2 5 0nm。结果 :马来酸伊索拉定在 10 .0～ 2 5 0 .0 μg ml 1的浓度范围内呈良好的线性关系 (r=0 .99999) ,平均回收率为 10 0 .5 % ,RSD =1.49% (n =6 )。结论 :本法快速、简便、准确。

OBJECTIVE:A HPLC method was estalished for the determination of IrsogladineMaleate. METHOD:The analytical column was Lichrospher  100RP 18e (5μm). The mobile phase was consisted of ocetonitrile purified water glacial acetic acid(250:750:3).The detection wavelength was at 250nm.RESULTS:The calibration curve was linear in the range of Irsogladine Maleate from10.0～250.0μg·mL 1 (r=0.99999).The average recovery was 100.5%, with RSD of 1.49%( n =6). CONCLUSION:The method is simple﹑rapid﹑accurate.