非诺贝酸有关物质的HPLC法测定

Determination of Related Substances in Fenofibric Acid by HPLC

建立了高效液相色谱法测定非诺贝酸的有关物质。以苯基硅烷键合硅胶为填充剂,流动相为乙腈-10 mmol/L磷酸二氢钾溶液(1︰1,用磷酸调至pH 2.5),检测波长289 nm。非诺贝酸的最低检测限为1 ng,关键中间体和破坏性试验产生的降解产物和非诺贝酸均能有效分离。

An HPLC method was established for the determination of the related substances in fenofibric acid.A phenyl column was used with the mobile phase of acetonitrile-10 mmol/L potassium dihydrogen phosphate solution （1︰1,adjusted to pH 2.5 with phosphoric acid） at the detection wavelength of 289 nm.The low limit of detection was 1 ng.The key intermediate and degradation products generated by destructive experiments could be separated effectively with fenofibric acid.