A Study on the Stability and Safety of an Extemporaneous Preparation of 2% Ganciclovir Eye Drops

Abstract

Background: This study aimed to establish a high-performance liquid chromatography method for the detection of ganciclovir eye drops and to assess the stability and safety of 2% topical ganciclovir eye drops prepared in hospitals. Methods: 2% ganciclovir solutions were prepared by dilution of a ganciclovir IV Infusion into saline and stored in a light-shielded container at 4, 25, or 37 °C for 4 weeks. The ganciclovir solution concentrations were determined by high-performance liquid chromatography on days 0, 1, 3, 7, 14, 21, and 28, respectively. Rabbits were used to assess ocular irritation following topical administration of ganciclovir solutions. Results: The concentration and pH of 2% ganciclovir were maintained at the initial levels for 4 weeks. All the prepared 2%ganciclovir eye drops remained colorless and clear without precipitation for 4 weeks, except for one sample which showed white precipitation after 3 weeks at 4 °C. No ocular irritation was observed in the eyes of rabbits. Conclusions: The drug in eye drop form was chemically stable for up to 4 weeks. The administration of 2% ganciclovir eye drops in rabbits did not show ocular irritation, suggesting safe dosage for use.