目的 采用HPLC法测定非诺贝特缓释片中非诺贝特。方法 采用Dikma C₁₈色谱柱（200 mm×4.6 mm，5 μm）；流动相：甲醇–水（90：10）；检测波长：288 nm；柱温：25 ℃；体积流量：1.0 mL/min；进样量10 μL。结果 非诺贝特在2.0～12.0 μg/mL与其峰面积呈良好的线性关系（r=0.999 9）；检测限和定量限分别为10、30 ng/mL；平均回收率为99.86%，RSD值为0.72%（n=9）。结论 该方法准确、简便，可用于非诺贝特缓释片中非诺贝特的质量控制。

Objective To establish an HPLC method for determining fenofibrate in Fenofibrate Sustained-release Tablets. Methods HPLC was carried out on a Dikma C₁₈ column (200 mm × 4.6 mm, 5 μm) with methanol - water (90:10) as mobile phase. The detection wavelength was set at 288 nm. The injection volume was 20 μL at the flow rate of 1.0 mL/min. The temperature of column was set at 25 ℃. Results There were good linear relationship of fenofibrate in the range of 2 — 12 μg/mL (r = 0.999 9). The limits of detection and quantitation were 10 and 30 ng/mL, respectively. The average recoveries was 99.86% with RSD value of 0.72% (n = 9). Conclusion The method is accurate and simple for quality control of fenofibrate in Fenofibrate Sustained-release Tablets.

国家重点基础研究发展计划（973计划）项目（2012CB724001）