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目的:建立环倍滴耳液中盐酸环丙沙星与丙酸倍氯米松含量测定的方法。方法:采用HPLC法同时测定环倍滴耳液中盐酸环丙沙星与丙酸倍氯米松的含量。色谱条件:ThermoODShypersilC18柱(4.6mm×150mm,5μm),以甲醇-0.05mol.L-1磷酸溶液(用三乙胺调至pH2.6)-乙腈为流动相进行多步梯度洗脱,检测波长分别为278,240nm,流速1.0mL·min-1,柱温为室温,进样量20μL。结果:盐酸环丙沙星在25～400mg·mL-1范围内,峰面积与浓度的线性关系良好(r=0.9995),平均回收率为99.2%;丙酸倍氯米松在3.12～50.0mg·mL-1范围内,峰面积与浓度的线性关系良好(r=0.9999),平均回收率为99.8%。结论:本方法快速、简便,精密度好,重复性好,可作为环倍滴耳液的含量控制方法。
Objective: To establish a method for determination of Ciprofloxacin Hydrochloride and Beclomethasone Propionate. Methods: Simultaneous determination of ciprofloxacin hydrochloride and beclomethasone dipropionate in ring-ear ear drops by HPLC. Chromatographic conditions: Thermo ODShypersil C18 column (4.6mm × 150mm, 5μm) with methanol -0.05mol.L-1 phosphoric acid solution (adjusted to pH2.6 with triethylamine) - acetonitrile as the mobile phase gradient elution, detection wavelength Respectively 278,240nm, flow rate 1.0mL · min-1, the column temperature was room temperature, injection volume 20μL. Results: The linear range of peak area was linear with the concentration of ciprofloxacin (r = 0.9995) in the range of 25-400 mg · mL-1, the average recovery was 99.2%. The average concentration of beclomethasone was 3.12-50.0 mg · mL-1, the linear relationship between peak area and concentration was good (r = 0.9999), and the average recovery was 99.8%. Conclusion: The method is rapid, simple, good precision and reproducibility, and can be used as a method for content control of ring ear drops.