Method for detecting related substances in domperidone tablet

• Main Authors: XU HAIXIA, LI XIAOZHANG, LIU YANYU, LIU KANGLAN
• Format: Patent
• Language: Chinese; English
• Published: 07.03.2023
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a method for detecting related substances in domperidone tablets, and relates to the field of analytical chemistry. The detection method comprises the following steps: mixing a domperidone tablet with a diluent to obtain a test solution; injecting the test solution into a liquid chromatograph, loading the test solution to a chromatographic column, and carrying out gradient elution by using a mobile phase A and a mobile phase B to separate domperidone from impurities in the test solution; the mobile phase A and the mobile phase B are respectively a mixture composed of a 0.5% acetate buffer solution, methanol and acetonitrile, and the volume ratio of the 0.5% acetate buffer solution to the methanol to the acetonitrile in the mobile phase A is (59-61): 35: (4-6); the volume ratio of the 0.5% acetate buffer solution to the methanol to the acetonitrile in the mobile phase B is (20-30): 30: (40-50); and testing the separated domperidone and impurities by adopting a detector to obtain a spect