Spectroscopic analysis reveals a novel process-related impurity in Apixaban intermediate APN-05, indicating double-bond reduction during chemical synthesis.
In this report, we describe the identification of new process related impurity observed during the preparation of Apixaban-An anticoagulant drug. As a part of the investigation, we isolated the impurity by column chromatography with > 96% purity and analyzed the sample of impurity by LC-MS, IR and NMR spectroscopy. The LC-MS analysis coupled with IR and NMR analysis suggested that the impurity is 1-(4-aminophenyl)-3-morpholinopiperidin-2-one, generated during preparation of Apixaban intermediate (APN-05). The impurity is a reduced form of APN-05 possibly formed due to reduction of ring double bond of dihydropyridin-2(1H)-one moiety of APN-05.
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Kumar et al. (2024) studied this question.
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