Quality Control of Tacrolimus Ophthalmic Emulsion

OBJECTIVE To establish the quality standard of tacrolimus ophthalmic emulsion. METHODS Quality standard of tacrolimus ophthalmic emulsion was established according to ChP, and its content was determined by HPLC. Stimulus of tacrolimus on rabbits' eyes and stability of tacrolimus ophthalmic emulsion were observed. RESULTS The calibration curve of tacrolimus was linear within the concentration range of 6.25-200 mg·mL-1，r＝0.999 9. The average recovery rate of tacrolimus was 99.83% (RSD=0.59%), and the RSD of the repeatability test was 1.04% (n=6). Tacrolimus had no stimulus on rabbits' eyes and its stability was relatively good. CONCLUSION The method is simple, quick and specific. It can be used to contorl the quality of tacrolimus ophthalmic emulsion.