目的 建立HPLC法测定氟比洛芬凝胶贴膏中有关物质。方法 使用Agilent Zorbax XDB-C₁₈色谱柱（150 mm×4.6 mm，5μm）；流动相A为乙酸水溶液（5∶60），流动相B为乙腈，梯度洗脱；柱温为30 ℃；检测波长为254 nm；体积流量为1.0 mL/min；进样体积为20 mL。采用加校正因子的主成分自身对照法计算氟比洛芬凝胶贴膏样品中降解杂质氟比洛芬甘油酯（杂质A）和氟比洛芬薄荷酯（杂质B）。结果 杂质A、B分别在0.01～5.40、0.10～16.20µg/mL线性关系良好。平均回收率分别为98.9%、97.9%，RSD值分别为1.0%、2.2%。结果均符合限度要求。结论 本方法操作简单，试剂易得，重现性好，能够有效分离并定量氟比洛芬凝胶贴膏中杂质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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