Detection method and application of related substances of pezopanib hydrochloride intermediate PZP-M2

• Main Authors: WANG LEI, WANG HONGFANG, LU HUI, ZHANG HUI, SONG SULI
• Format: Patent
• Language: Chinese; English
• Published: 09.06.2023
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention relates to the technical field of chemical drug analysis methods, in particular to a detection method and application of related substances of a pezopanib hydrochloride intermediate PZP-M2. The detection method comprises the following steps: detecting a test solution by adopting high performance liquid chromatography; the PZP-M2 is N-(2-chloropyrimidine-4-yl)-N-methyl-2, 3-dimethyl-2H-indazole-6-amine, and the PZP-M2 is N-(2-chloropyrimidine-4-yl)-N-methyl-2 The detection conditions of the high performance liquid chromatography are as follows: the detection wavelength is 210-214 nm; a 0.009-0.011 mol/L aqueous solution of monopotassium phosphate with the pH value of 3.1-3.3 is used as a mobile phase A, and acetonitrile is used as a mobile phase B for gradient elution; according to the detection method, related substances of six impurities controlled in the pezopanib hydrochloride intermediate PZP-M2 can be efficiently separated at a time, and the detection method is high in specificity, good in