Method for detecting enantiomer in Avapritinib intermediate

• Main Author: CHEN NIANGEN
• Format: Patent
• Language: Chinese; English
• Published: 23.11.2021
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention provides a method for detecting an enantiomer of an Avapritinib key intermediate. The adopted chromatographic conditions are as follows: the chromatographic column is CHIRALCEL*OD-H 4.6*250 mm, 5 [mu]m, the column temperature is 30 DEG C, the detection wavelength is 220 nm, the mobile phase is normal hexane, ethanol and isopropanol in a ratio of (99-102):(0.1-1):0.5, and the flow velocity is 0.8-1.0 mL/min. By adopting the method, quantitative analysis of the enantiomer (R)-1-(4-fluorophenyl)-1-[2-(piperazine-1-yl)pyrimidine-5-yl]ethylamine in (S)-1-(4-fluorophenyl)-1-[2-(piperazine-1-yl)pyrimidine-5-yl]ethylamine can be accurately carried out, the enantiomer can be effectively separated and detected, the peak pattern is symmetrical, the tailing phenomenon is avoided, the separation degree, the specificity, the quantitation limit, the detection limit, the linearity, the repeatability, the accuracy degree, the precision, the solution stability and the durability all meet the requirements, and the