目的 建立HPLC法測定氟比洛芬凝膠貼膏中有關(guān)物質(zhì)。方法 使用Agilent Zorbax XDB-C₁₈色譜柱（150 mm×4.6 mm，5μm）；流動相A為乙酸水溶液（5∶60），流動相B為乙腈，梯度洗脫；柱溫為30 ℃；檢測波長為254 nm；體積流量為1.0 mL/min；進(jìn)樣體積為20 mL。采用加校正因子的主成分自身對照法計(jì)算氟比洛芬凝膠貼膏樣品中降解雜質(zhì)氟比洛芬甘油酯（雜質(zhì)A）和氟比洛芬薄荷酯（雜質(zhì)B）。結(jié)果 雜質(zhì)A、B分別在0.01～5.40、0.10～16.20µg/mL線性關(guān)系良好。平均回收率分別為98.9%、97.9%，RSD值分別為1.0%、2.2%。結(jié)果均符合限度要求。結(jié)論 本方法操作簡單，試劑易得，重現(xiàn)性好，能夠有效分離并定量氟比洛芬凝膠貼膏中雜質(zhì)A、B。

Objective To develop an HPLC method for determination of related substances in Flurbiprofen Gel Plaster by HPLC. Methods Agilent Zorbax XDB-C₁₈ column (150 mm × 4.6 mm, 5 μm) was used, mobile phase A was acetic acid aqueous solution (5∶60), mobile phase B was acetonitrile, with gradient elution. The column temperature was 30 ℃, detection wavelength was set at 254 nm, flow rate was 1.0 mL/min, and injection volume was 20 μL. Determination of the degradation impurities flurbiprofen glycerol ester (impurity A) and flurbiprofen menthyl ester (impurity B) in Flurbiprofen Gel Plaster were calculate by principal component self-comparison method with a correction factor. Results The linear range of impurity A and B was 0.01 — 5.40 and 0.10 — 16.20 µg/mL. The average recovery was 98.9% and 97.9%, with RSD 1.0% and 2.2%. The results met the limit requirements. Conclusion The method is simple to operate, easy to obtain reagents, and has good reproducibility, and can effectively separate and quantify impurities A and B in Flurbiprofen Gel Plaster.

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