Method for controlling impurity of cyclosporin a eye gel
AssigneeZhaoke (Guangzhou) Ophthalmic Drug Company Limited
InventorsGang Li, Kailei Cao, Xiaoyi Li, Xiangrong Dai, Lei Yin, Juan Ling
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Abstract
A method of controlling the impurities in a cyclosporin A eye gel. A high performance liquid chromatography is performed, and chromatographic conditions are as follows: the detection wavelength is 210-230 nm; the column temperature is 60-68° C.; the flow rate is 0.8-1 ml/min; and the mobile phase A is: THF-water-phosphoric acid. The method of controlling impurities solves the problem of excipients interference and separation of many impurities at the same time, it also provides an effective method for the formulation of quality standard of impurities in this kind of preparation.
Claims7
A method of controlling the impurities in a cyclosporin A eye gel, comprising:
- performing high performance liquid chromatography, wherein, chromatographic conditions are as follows:
- a detection wavelength is 210-230 nm;
- a column temperature is 60-68° C.;
- a flow rate is 0.8-1 ml/min;
- and
- a mobile phase is THF-water-phosphoric acid.
Dependencies are inferred from the claim text.