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publicationDate 2021-11-05-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-113607870-A
titleOfInvention Method for detecting polymer impurities in cefadroxil bulk drug and preparation thereof
abstract The invention provides a method for detecting polymer impurities in a cefadroxil bulk drug or a preparation thereof, which is based on a reversed-phase high-performance liquid chromatography and comprises the steps of establishing chromatographic conditions and preparing a polymer impurity positioning reference solution; wherein the chromatographic conditions are: stationary phase: octadecylsilane chemically bonded silica, mobile phase: taking 0.02mol/L potassium dihydrogen phosphate solution with the pH value of 4.8-5.2 as a mobile phase A, taking methanol as a mobile phase B, and performing gradient elution; flow rate: 0.9-1.1 ml/min; column temperature: 28-32 ℃; detection wavelength: 220 nm. The method for detecting the polymer impurities in the cefadroxil bulk drug or the preparation thereof can simultaneously detect various polymer impurities, the separation degree of each polymer impurity is good, and the method can eliminate the interference of small molecular impurities in the cefadroxil bulk drug or the preparation thereof.
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