Preparation and Quality Control of Gatifloxacin Chitosan Eye Drops / 中国药房

ABSTRACT

OBJECTIVE:To prepare gatifloxacin chitosan eye drops and to establish its quality control.METHODS:The eye drops was prepared with chitosan as the base.The content of gatifloxacin was determined by UV spectrophotometry and the stability of the preparation was detected by initial average accelerated method.RESULTS:The linear range for gati?floxacin was5.0～15.0?g/ml(r=0.9990,n=5),the average recovery rate was98.91%(RSD=1.43%).The activation energy for pyrolytic reaction of gatifloxacin chitosan eye drops was25.91kcal/mol,its shelflife at25℃and10℃were93.8days and950days,respectively.CONCLUSION:The preparation technology is feasible and the quality control method is reliable.