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目的:建立复方左氧氟沙星喷雾剂的制备及含量测定方法。方法:依据组分理化性质确定配制工艺;含量测定采用 DZKMA C18(200 mm×4．6 mm,0．5μm)不锈钢柱,以0．025 mol·L-1磷酸液:乙睛(87:13)为流动相,流速:1 ml·min-1,紫外检测波长278 nm。结果:左氧氟沙星浓度在12．5-400μg·ml-1范围内有良好的线性关系(r=0．999 9),平均回收率99．90％, RSD0．02％;更昔洛韦浓度在6．25-200μg·ml-1范围内有良好的线性关系(r=1．000 0),平均回收率99．96％,RSD 0．06％。结论:复方左氧氟沙星喷雾剂处方设计合理、工艺简便、剂型稳定可控、含量测定方法准确,适于医院使用。
Objective: To establish the preparation and content determination of compound levofloxacin spray. Methods: According to the physical and chemical properties of the components, the preparation process was determined. The content was determined by DZKMA C18 (200 mm × 4.6 mm, 0.5 μm) stainless steel column, 0.025 mol·L-1 phosphoric acid solution ) As mobile phase, flow rate: 1 ml · min-1, UV detection wavelength of 278 nm. Results: The levofloxacin concentration in the range of 12.5-400μg · ml-1 had a good linear relationship (r = 0.999 9), with an average recovery of 99.90% and RSD of 0.02%. The concentration of ganciclovir at 6 There was a good linear relationship (r = 1.000 0) in the range of 25-200 μg · ml-1 with an average recovery of 99.96% and RSD 0.06%. Conclusion: The formulation of compound levofloxacin spray is reasonable in design, simple in process, stable and controllable dosage form, accurate in determination of content, and suitable for hospital use.