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filingDate 2019-05-31-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2022-05-24-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2022-05-24-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-110133149-B
titleOfInvention Method for separating and measuring LCZ696 and impurities thereof
abstract A method for separating and measuring LCZ696 and impurities thereof comprises the following steps of 1) taking LCZ696 or a preparation containing LCZ696, adding a diluent for dissolving to obtain a sample solution with the concentration of 0.1-10 mg/ml; 2) taking the sample solution obtained in the step 1), and adding a diluent to dilute by 50-1000 times to obtain a reference solution; 3) the method comprises the following steps of (1) adopting a chromatographic column with octadecylsilane chemically bonded silica as a filler, setting the flow rate of a mobile phase to be 0.8-1.2ml/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 concentration of 0.0001-1.0mol/L, 0.0001-10 parts by volume of triethylamine is added into 100 parts by volume of the buffer solution, the mobile phase B is an acetonitrile-methanol mixed solution, the volume ratio of acetonitrile to methanol is 55-45:45-55, 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 impurities in the sample solution.
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