The invention discloses a method for detecting related substances in an
amoxicillin raw material and a preparation thereof, and relates to the technical field of pharmaceutical analysis, HPLC conditions are as follows: the
elution gradient is 0-5 min: 100% mobile phase A; in 5-25 min, 100%-94% of the mobile phase A and 0-6% of the mobile phase B are adopted; 25-40 min, 94%-84% of the mobile phase A and 6%-16% of the mobile phase B are adopted; 40-50 minutes: 84% of the mobile phase A and 16% of the mobile phase B; 50-51min: 84% of the mobile phase A, 100% of the mobile phase A and 16-0% of the mobile phase B; and in 51-60 min, 100% of the mobile phase A is adopted. The method for detecting the related substances of the
amoxicillin related varieties, which is recorded and published by various Chinese pharmacopoeias and literatures, is confirmed, and a set of more effective
high performance liquid chromatography is established and verified by screening and optimizing
liquid phase conditions such as chromatographic columns and mobile phases, particularly
chromatographic column brands, fillers, models and the like; the
quality control can be simultaneously carried out on process impurities, degradation impurities, polymers and other organic impurities of
amoxicillin raw materials and preparations thereof, so that the occurrence of adverse reactions such as
anaphylaxis and the like is reduced, and the safety and effectiveness of medication are ensured.