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

ABSTRACT

OBJECTIVE:To prepare ganciclovir hydrochloride chitosan eye drops and establish its quality control method.METHODS:The eye drops was prepared using chitosan as thickening agent and synergist with ganciclovir as principal agent.The content of ganciiclovir was determined by HPLC.The stability of the preparation was investigated as well.RESULTS:The prepared eye drops was colorless transparent glutinous limpid liquid with its identification items all up to the related standards stipulated in Chinese Pharmacopoeia(2005 edition).The linear range of ganciclovir was 5～80 mg?L-1(r=0.999 9) with average recovery of 99.02%(RSD=0.71%).The preparation was stable under light with all its indexes showed no obvious change in the accelerated test at 6 month.CONCLUSION:The preparation technology is simple and feasible and the quality of preparation is stable and controllable with a validity duration tentatively set at 2 years.