高效液相色谱法测定氢溴酸达非那新的含量

Determination of darifenacin hydrobromide with HPLC

目的用高效液相色谱法对氨溴酸达非那新的含量进行了测定。方法[1]色谱柱KromasilC18;流动相甲醇-磷酸盐缓冲液(55:45);检测波长230 nm。结果本品线性范围为25.99 g/mL～259.9 g/mL,r=0.9995;含量平均值是99.85%;RSD%均小于0.2%,故选择了100 g/mL为含量测定浓度。结论本试验方法用于测定氢溴酸达非那新的含量时,方法简单,准确度较高;重复性好;稳定性高。可以有效的控制氢溴酸达非那新的含量。

Objective To determine the ammount of with HPLC method. Methods Kromasil C18 column, methanol- of phosphate （55：45）as mobile phase, 230 nm detection wavelength were applied in the experiment. The flow rate was 1.0 ml ·min. Results The linear range of darifenaein hydrobromide was 25.99-259.9 g/mL, coeficient correlation （r was 0.9995）,the average recovery of darifenacin jydrobromide was 99.85 %, RSD % was less than 0.2% ,so the consistence of 100 g/mL was choosed as the testing consistence. Conclusion The method is simple, rapid, accurate and repreatable. It can be used for the determination of darifenaein hydrobromide .