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filingDate 2019-05-31-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2022-04-12-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2022-04-12-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-110133150-B
titleOfInvention Method for separating and measuring LCZ696 isomer impurities
abstract A method for separating and determining LCZ696 isomer impurities, comprising the steps of: 1) dissolving LCZ696 or preparation containing LCZ696 with diluent to obtain sample solution with concentration of 0.1-10 mg/ml; 2) taking the sample solution obtained in the step 1), and adding a diluent to dilute the sample solution by 50-1000 times to obtain a control solution; 3) adopting a polysaccharide derivative or cellulose derivative reverse-phase coating type chiral chromatographic column, setting the flow rate of a mobile phase to be 0.4-0.8ml/min, wherein the mobile phase consists of a mobile phase A and a mobile phase B, the mobile phase A is a buffer solution with the volume concentration of 0.0001-1.0%, the mobile phase B is an acetonitrile-methanol mixed solution, the volume ratio of acetonitrile to methanol is 75-85:25-15, 100 parts by volume of the mobile phase B is added with 0-1 part by volume of phosphoric acid, and the mobile phase enters the chromatographic column by adopting a gradient elution mode; 4) injecting equal volumes of the sample solution in the step 1) and the control solution in the step 2) into a high performance liquid chromatograph respectively, wherein the injection amount is 5-100 mu l, detecting by using the wavelength of 200-280 nm, recording a chromatogram, and completing the separation and determination of the isomer in the sample solution.
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