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

摘要: 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10 μL。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0.54~3.23 μg·mL^-1（r=0.999 9），检测限为0.03 μg·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。

Abstract: 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.