Content Determination and Stability of Ciclosporin Ophthalmic Emulsion
- VernacularTitle:环孢素眼用乳状液的含量测定及稳定性研究
- Author:
Yandong WANG
;
Xilan TANG
;
Chengtian YE
;
Wei WU
- Publication Type:Journal Article
- Keywords:
Ciclosporin;
Ophthalmic emulsion;
HPLC;
Stability
- From:
China Pharmacy
2005;0(13):-
- CountryChina
- Language:Chinese
-
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.
