左氧唑滴耳液的制备与质量控制

Preparation and Quality Control of Levofloxacin and Tinidazole in Auristilla

目的采用复方协同效应制备以左氧氟沙星和替硝唑为主药的左氧唑滴耳液,并建立左氧唑滴耳液质量控制方法。方法采用双波长分光光度法直接测定左氧唑滴耳液中主药的含量,以留样观察法考察其稳定性。结果该制剂中两主药平均回收率分别为98.52%和98.14%。结论该滴耳液制备工艺简单,性质稳定,含量测定方法快速准确,适于医院制剂室配制和应用。

Objective To prepare an auristilla with complex synergistic effect, consisting of levofloxacin and tinidazole, and to establish its quality control method. Methods The contents of levofloxacin and tinidazole in aufistilla were determined hy dual wavelength spectrophotometry. Its stability was investigated by observation on retained sample. Results The average recovery of levofloxacin and tinidazole is 98.52% and 98.14%, respectively. Conclusion The method of auristilla preparation is simple with stable quality. The method of assay is accurate and fast. This auristilla is suitable to the preparation and application in hospital.