HPLC-UV法同时测定恩他卡朋原料药中3种有机酸的含量

Simultaneous Determination of Three Organic Acids in Entacapone by HPLC-UV

建立高效液相色谱-紫外检测器(high performance liquid chromatography with UV detection,HPLC-UV)法测定恩他卡朋原料药中残留的甲酸、乙酸、氰基乙酸。采用Welch Ultimate XB-C_(18)柱(4.6 mm×250 mm,5μm),以0.01 mol/L磷酸二氢钾(pH 2.0)溶液为流动相A,甲醇为流动相B,梯度洗脱,流速为1 ml/min,检测波长为210 nm,进样量为20μl,柱温为30℃。本方法简便、准确,专属性强、灵敏度高,可同时检测恩他卡朋原料药中残留的3种有机酸。

A high performance liquid chromatography with UV detection(HPLC-UV)method was established for the determination of formic acid,acetic acid and cyanoacetic acid in entacapone active pharmaceutical ingredient(API).A Welch Ultimate XB-C18 column(4.6 mm×250 mm,5μm)was used.And 0.01 mol/L of potassium dihydrogen phosphate(pH 2.0)solution was used as mobile phase A and methanol as mobile phase B for gradient elution.The flow rate was 1 ml/min,the detection wavelength was 210 nm,the injection volume was 20μl,and the column temperature was 30℃.The method is simple,accurate,specific and sensitive,which can be used for the simultaneous determination of the three acids in entacapone.