Stability of Dexamethasone Sodium Phosphate Eye Drops / 中国药房

ABSTRACT

OBJECTIVE: To study the stability of dexamethasone sodium phosphate(DSP) eye drops and predict its validity duration.METHODS: The content of DSP in eye drops was determined by HPLC and its validity duration was predi-cated using initial average rate method.RESULTS: The linear concentration range of DSP was 18～70 ?g?mL-1(r=0.999 9) with an average recovery rate of 99.74%(RSD=0.37%).The content of DSP in the eye drops decreased as its storing temperature increased and the storing time prolonged,but its pH was stable. The validity duration of the eye drops was computed to be 70 days at 25 ℃ and 438 days at 4 ℃.CONCLUSION: This eye drops were stable at 4 ℃.