HPLC测定非诺贝特缓释胶囊的有关物质

Determination of Related Substances of Fenofibrate Extended Release Capsules by HPLC

目的建立非诺贝特缓释胶囊有关物质的HPLC测定方法。方法采用Kromasil-100-5 C18柱,流动相为乙腈-水(用磷酸调节pH至3.0)(67∶33);流速1.0 mL·min^(-1);检测波长为286 nm;柱温为40℃;进样量为10μL。结果非诺贝特与其他杂质的分离度较好,非诺贝特的线性范围为0.54～3.23μg·mL^(-1)(r=0.999 9),检测限为0.03μg·mL^(-1)。结论建立的方法简便、准确、专属性强,可作为非诺贝特缓释胶囊有关物质的检测方法。

OBJECTIVE To establish an HPLC method for related substances determination of Fenofibrate Extended Release capsules. METHODS The Kromasil-100-5 C18 column was used. The mobile phase was acetonitrile-water(pH 3.0)(67∶33) at the flow rate of 1.0 mL·min-1. The detection wavelength was 286 nm and column temperature was 40 ℃. The injection volume was 10 μL. RESULTS The separation of fenofibrate and its related substances was good. The calibration curves of fenofibrate was linear in the range of 0.54?3.23 μg·mL-1(r=0.999 9), and its detection limit was 0.03 μg·mL-1.CONCLUSION The method is rapid, accurate and reliable for related substances determination of Fenofibrate Extended Release capsules.