Objective:To develop a method for characterizing in vitro release of cyclosporine ophthalmic emul-sion.Methods:The Franz diffusion cell and the polyvinylidene fluoride membrane were adopted with buffer-eth-anol(40∶60)as receiving media.The sampling time was set at 60,125,190,255,320,385 min,respectively.Results:The in vitro release method showed that the inertia of membrane,specificity,sensitivity and selectivity met the requirements.The validation of HPLC showed that the quantitative limit of the method was 0.07 µg·mL-1 and a good linear relationship between the concentration range of 0.07-44.62 μg·mL-1.The average re-covery was 98.9％.Compared with the original preparation by FDA guideline,the in vitro release of the self-de-veloped preparation was the same as the reference preparation.Conclusions:This method is suitable for the in vitro release evaluation of cyclosporine eye drops.
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