Preparation and Quality Control of in-situ Gelling of Hydrochloride Sparfloxacin Eye Drops / 中国药房

ABSTRACT

OBJECTIVE:To prepare in-situ gelling of hydrochloride sparfloxacin eye drops and establish its quality con-trol method.METHODS:The in-situ gelling of hydrochloride sparfloxacin eye drops were prepared with boric acid as buffer to regulate the pH and osmotic pressure and with sodium polymannuronate as peptizer.The content of hydrochloride sparflo-xacin was determined by ultraviolet spectrophotometry.The stability of the sustained-release eye drops was investigated as well.RESULTS:The sustained-release eye drops were colorless or yellowish limpid liquid with its test and identification results all in conformity with the related stipulation stated in Chinese Pharmacopeia(2005 edition).There was a good linear relationship within the concentration range of 3.0～8.0 ?g?mL-1 for hydrochloride sparfloxacin,and its average recovery was 99.82%(RSD=0.236%,n=6).There was no significant change for indexes in the accelerate test and sample test,yet the temperature and lighting did have slight impact on the viscosity,osmotic pressure and pH of the solution.CONCLUSION:The preparative method is simple and feasible and the quality of in-situ gelling of hydrochloride sparfloxacin eye drops is stable and controllable.