Method for the analysis of related substances in cyclosporine a preparation, and use thereof
AssigneeZhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited
InventorZhijun Xie
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Abstract
A method for analysis of related substances in a cyclosporine A preparation is provided. Chromatographic conditions for the method are as follows: a detection wavelength: 210 nm to 230 nm; a column temperature: 50° ° C. to 60° C.; a flow rate: 0.8 mL/min to 1.5 mL/min; a mobile phase A: acetonitrile (0.085% phosphoric acid); a mobile phase B: isopropanol (0.085% phosphoric acid); and a mobile phase C: water (0.1% phosphoric acid). The method of the present disclosure can well solve problems such as interference of adjuvants and poor separation of many related substances, and also provides an effective means for formulation of quality standards for related substances in such a preparation.
Claims18
A method for an analysis of related substances in a cyclosporine A preparation, wherein the method refers to high-performance liquid chromatography, and is conducted under the following conditions:
- a chromatographic column with octadecylsilane-bonded silica gel as a packing;
- and mobile phases comprising:
- a mobile phase A, a mobile phase B, and a mobile phase C, wherein the mobile phase A is a phosphoric acid-acetonitrile solution with a concentration of phosphoric acid being 0.05% to 0.1%;
- the mobile phase B is a phosphoric acid-isopropanol solution with a concentration of phosphoric acid being 0.05% to 0.1%;
- and the mobile phase C is a phosphoric acid aqueous solution with a concentration of phosphoric acid being 0.05% to 0.2%.
Dependencies are inferred from the claim text.