Separation and Identification of Degradation Impurities of Esomeprazole Sodium

Biomed Chromatogr. 2023 Feb 2:e5593. doi: 10.1002/bmc.5593. Online ahead of print.ABSTRACTDrug impurities are important factors that affect drug safety and efficacy. The purpose of this study is to separate and confirm the structure of two degradation impurities of esomeprazole sodium, designated X and Y. The impurities X and Y were successfully isolated by preparative high-performance liquid chromatography via developing separation methods with the help of ACD/Labs AutoChrom software. There was a steady increase in X and Y impurities in forced esomeprazole sodium degradation. Impurity X was confirmed as 6-methoxy-1h-benzo[d]imidazole-2-yl-4-amino-3,5-dimethylpyridinecarboxylate, and impurity Y as 6-methoxy-1h-benzo[d]imidazole-2-yl-4-hydroxy-3,5-dimethylpyridinecarboxylate using nuclear magnetic resonance spectrometer, infrared spectroscopy, and high-resolution mass spectrometry. These findings allow a comprehensive understanding of the impurity profile of esomeprazole sodium since these impurities are reported for the first time. Based on our results, active pharmaceutical ingredient manufacturers can further control process parameters to reduce the generation of impurities, and drug production manufacturers can optimize the packaging and storage conditions of esomeprazole sodium.PMID:36733994 | DOI:10.1002/bmc.5593
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Source Type: research