氟康唑滴眼液的研制及质量控制

Preparation and Quality Control of Fluconazole Eyedrops

目的 :制备氟康唑滴眼液并控制其质量。方法 :采用高效液相色谱法测定滴眼液中氟康唑含量 ,依据《中国药典》对滴眼液进行质量控制。结果 :含量测定平均回收率为100 41 % ,RSD=0 54% (n=5)。结论 :该制剂处方合理 ,制备工艺简便 ,质量易于控制。

OBJECTIVE:To study the preparation of fluconazole eyedrops as well as its quality control.METHODS:The content of fluconazole in eyedrops was determined with HPLC.The quality control of eyedrops has done in accordance with ChP.RESULTS:The average recovery was100.4%,RSD=0.54%(n=5).CONCLUSION:The formula of this preparation is reasonable with simple and convenient technology.Moreover,its quality control is easy to handle.