高效液相色谱法测定非诺贝酸的含量和有关物质

Determination of Fenofibric Acid and its Related Substances by HPLC

建立同时测定非诺贝酸含量和有关物质的高效液相色谱法。采用苯基硅烷键合硅胶柱（4.6 mm×250 mm,5μm）,流动相为10 mmol/L磷酸二氢钾溶液（用磷酸调节p H值至2.5）-乙腈（35∶65）,体积流量为1.0 m L/min,检测波长为287 nm,柱温为室温。应用该色谱条件进行有关物质测定时,非诺贝酸与各有关物质之间分离度良好,各杂质对主成份的含量测定无影响。非诺贝酸浓度在0.100 2～1.002μg/m L范围内与峰面积呈现良好的线性关系,r=0.999 9,平均回收率为99.60%,99.81%,99.85%,RSD值为0.8%。定量限为50.25 ng。最低检出限为12.65 ng。3批样品的含量测定结果分别为99.10%,99.58%,100.02%。总杂质分别为：0.05%,0.07%,0.07%。该方法灵敏度高,简单易行,结果准确可靠,可用于测定非诺贝酸的含量和有关物质。

To establish a HPLC method for detemination of fenofibric acid and its related substances.A phenyl column（4.6 mm ×250 mm,5 μm） was used,the mobile phase for the content determination was acetonitrile-10 mmol / L potassium dihydrogen phosphate solution（65∶ 35,adjusted to p H 2.5 with phosphoric acid） at the detection wave length of 287 nm and the column temperature of room temperature.The results showed that fenofibric acid and its related substances were separated quite well under the above conditions.Excipients showed no interference with determination of the main component.Fenofibric acid concentration was within0.100 2 ～ 1.002 μg / m L range and the peak area exhibited a good linear relationship,and the correlation coefficient was 0.999 9,the average recovery was 99.60%,99.81%,99.85%,with RSD of 0.80%.The limit of detection was 50.25 ng,and the minimum detection limit of 12.65 ng.Determination results of three batches of samples were 99.10%,99.58%,100.02%,respectively.The total impurities were 0.05%,0.07% and 0.07%,respectively.The method is sensitive,simple,accurate and reliable for the determination of fenofibric acid and related substances.