复方氟康唑滴耳剂的制备及质量控制

Preparation and Quality Control of Compound Fluconazole Ear Drops

目的:制备复方氟康唑滴耳剂,并对其进行质量控制。方法:运用紫外分光光度法测定含量(双波长分光光度法测定氟康唑含量,单波长分光光度法测定替硝唑含量)。结果:氟康唑的线性范围为60～300μg/mL,回归方程C=-0.5989±714.365△A(r=0.9999,n=6),回收率为98.18%～102.39%;替硝唑的线性范围为5～25μg/mL,回归方程C=0.049±28.128A(r=0.9999,n=6),回收率为97.50%～102.73%。结论:复方氟康唑滴耳剂制备简单,质量稳定,无刺激性。

Objective: To prepare compound fluconazole ear drops and to control its quality.Methods:Using UV spectrophotometry to determine their contents (double wavelength of UV spectrophotometry to determine the content of fluconazole,single wavelength of UV spectrophotometry to determine the content of tinidazole).Results:The linear concentration range of fluconazole was 60～ 300 μ g/mL,the regression equation was C=- 0.598 9± 714.365△ A(r=0.999 9,n=6),the rate of recovery was 98.18% ～ 102.39% ;the linear concentration range of tinidazole was 5～ 25 μ g/mL,the regression equation was C=0.049± 28.128A(r=0.999 9,n=6),the rate of recovery was 97.50% ～ 102.73% .Conclusion:The preparation of compound fluconazole ear drops was simple,its quality was stable and it had no irritation.