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filingDate 2021-10-21-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2022-01-25-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-113970607-A
titleOfInvention Method for detecting related substances in balsalazide disodium capsule
abstract The invention relates to the technical field of medicine quality detection, and particularly discloses a high performance liquid chromatography analysis method for related substances in balsalazide disodium capsules. The method adopts a C18 chromatographic column, takes water as a diluent to prepare a sample to be detected, and uses an ultraviolet detector to carry out liquid chromatography quantitative analysis. The chromatographic conditions are as follows: the column temperature is 40-50 ℃, the detection wavelength is 235-245 nm, the flow rate is 0.8-1.2 mL/min, an ammonium acetate solution with the pH value of 6.5-7.5 is used as a mobile phase A, acetonitrile is used as a mobile phase B, and a gradient elution program is established, wherein the concentration of the ammonium acetate solution is 0.02-0.05 mol/L, and the pH regulator is an ammonia solution. Compared with the United states pharmacopoeia and the current domestic standard, the method increases the research on the key impurity biphenyl azo salicylic acid, has the advantages of more detectable impurities, good peak shape and high separation degree, and improves the accuracy of impurity detection and the quality controllability of products.
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