RP-HPLC法测定马来酸伊索拉定口腔崩解片药物含量

目的建立马来酸伊索拉定口腔崩解片中药物含量测定方法。方法采用RP HPLC法。Spherisorb C8柱( 4 6mm×2 5 0mm ,10 μm,大连依利特) ;流动相为甲醇 水 冰醋酸(体积比6 0∶4 0∶0 5 6 ) ,柱温为室温;流速1mL·min-1,紫外检测波长2 5 0nm。结果在选择的色谱条件下马来酸伊索拉定与辅料及溶剂峰分离良好,马来酸伊索拉定质量浓度在5 0～2 5 0mg·L-1内线性关系良好(r =0 9998,n =5 ) ,回收率在99 5 %～10 1 3%之间,日内RSD及日间RSD均小于2 % (n =5 )。结论该方法可用于马来酸伊索拉定口腔崩解片中药物含量测定。

Determination of content of irsogladine maleate orally disintegrating tablets by RP-HPLC

Objective To establish a RP-HPLC method for the determianation of the content of irsogladine maleate orally disintegrating tablets.Methods The separation was performed with a Spherisorb-C 8 column( 4.6 mm × 250 mm , 10 μm ),and the mobile phase was CH 3OH-H 2O-glacial acetic acid ( V∶V∶V= 60∶40∶0.56 ),flow rate was 1 mL·min~ -l and irsogladine maleate was detected at 250 nm , temperature was about 25℃.Results Irsogladine maleate had a good linear relation in the range of 50～ 250 mg·L~ -1 ( r= 0.999 8 ,n=5),the intra-day RSD and inter-day RSD were less than 2%, the average recovery was between 99.5%～101.3%.Conclusion This method is applicable for determination of content of irsogladine maleate orally disintegrating tablets.