HPLC法同时测定富马酸伏诺拉生中富马酸和马来酸

Simultaneous Determination of Fumaric Acid and MaleicAcid Content in Fumarate by HPLC Method

建立一种可同时检测富马酸伏诺拉生中富马酸与马来酸含量的高效液相分析方法。C 8色谱柱,以0.05 mol/L磷酸二氢钾缓冲液-甲醇(体积比95∶5)为流动相A、乙腈为流动相B,梯度洗脱。富马酸在50%~150%浓度水平范围内线性关系良好,定量下限为0.7491μg/mL;马来酸在LOQ~200%浓度水平范围内线性关系良好,定量下限为0.4100μg/mL;精密度试验中12份供试品溶液的RSD均小于2.0%。方法精密度及耐用性良好,且简单灵敏,可用于同时检测富马酸伏诺拉生中富马酸与马来酸的含量。

A high-performance liquid chromatography method was established to simultaneously detect the content of fumaric acid and maleic acid in fumarate fumarate fumarate fumarate.C8 chromatography column,using 0.05 mol/L potassium dihydrogen phosphate buffer methanol(95∶5,V/V)as mobile phase A and acetonitrile as mobile phase B,gradient elution.Fumaric acid has a good linear relationship within the concentration range of 50%to 150%,with a lower limit of quantification of 0.7491μg/mL;The linear relationship of maleic acid is good within the concentration range of LOQ-200%,with a lower limit of quantification of 0.4100μg/mL;The RSD of all 12 test solutions in the precision test was less than 2.0%.This method has good precision and durability,and is simple and sensitive.It can be used to simultaneously detect the content of fumaric acid and maleic acid in fumarate.