Content Determination and Stability of Ciclosporin Ophthalmic Emulsion / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for the content determination of Ciclosporin ophthalmic emulsion and to probe into its stability.METHODS:HPLC method was used to determine the content of ciclosporin.The separation was performed on Eclipse XDB-C8 column.The mobile phase consisted of acetonitrile-methanol-water(67.5 :5 :27.5) with the flow rate of 0.8 mL?min-1.The detection wavelength was set at 210 nm and column temperature was 55 ℃.Its stability was studied by classic isothermal accelerated test and highlight struck test.RESULTS:The linear range of ciclosporin was 5～60 mg?L-1(r=0.999 9) with average recovery of 100.39%(RSD=1.15%).The preparation was stable under heat and light,and its shelf life at 25 ℃ was predicted about 6.88 years.CONCLUSIONS:The method is accurate and feasible for the content determination of Ciclosporin ophthalmic emulsion.The preparation can be stored at room temperature.