HPLC法测定氟芬那酸丁酯软膏的有关物质

Determination of related substances in butyl flufenamate ointment by HPLC

目的建立用于氟芬那酸丁酯软膏有关物质测定的HPLC法,为建立氟芬那酸丁酯软膏的质量控制标准提供依据。方法采用梯度洗脱,流速:1.0 m L·min-1,检测波长:287 nm,柱温:35℃,进样量:20μL。结果在所建立的色谱条件下,氟芬那酸丁酯能与各杂质得到有效分离,杂质I、杂质II在各自质量浓度范围内线性关系良好(r>0.999);平均回收率分别为94.4%、96.4%。结论本方法可用于氟芬那酸丁酯软膏的质量控制。

Objective To establish a method for determination of related substances in butyl flufenamate ointment. Methods Separation was performed on a Kromasil C18 （200 mm × 4. 6 mm, 5 μm） column with gradient elution using acetonitrile as mobile phase A and 1% acetic acid solution as mobile phase B. The flow rate was 1.0 mL·min^- 1 and the detection wavelength was set at 287 nm. The column temperature was 35℃ and injection volume was 20μL. Results Butyl flufenamate can be separated from other impurities. The calibration curves for butyl flufenamate impurity I and II are linear in each range of concentration （ r 〉 0. 999）. The recovery of impurities are 94. 4% and 96. 4%. Conclusions This method is simple and accurate, and it can be used for the quality control of butyl flufenamate ointment.