目的 采用HPLC法測定非諾貝特緩釋片中非諾貝特。方法 采用Dikma C₁₈色譜柱（200 mm×4.6 mm，5 μm）；流動相：甲醇–水（90：10）；檢測波長：288 nm；柱溫：25 ℃；體積流量：1.0 mL/min；進(jìn)樣量10 μL。結(jié)果 非諾貝特在2.0～12.0 μg/mL與其峰面積呈良好的線性關(guān)系（r=0.999 9）；檢測限和定量限分別為10、30 ng/mL；平均回收率為99.86%，RSD值為0.72%（n=9）。結(jié)論 該方法準(zhǔn)確、簡便，可用于非諾貝特緩釋片中非諾貝特的質(zhì)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.

國家重點基礎(chǔ)研究發(fā)展計劃（973計劃）項目（2012CB724001）