Synthesis and Characterization of Metabolites and Potential Impurities of Lansoprazole, an Antiulcerative Drug

Abstract

Lansoprazole (Prevacid) is an antiulcerative drug used for the treatment of duodenal and gastric ulcers, reflux oesophagitis, and Zollinger–Ellison syndrome. During the bulk synthesis of lansoprazole, we have observed five impurities: lansoprazole N-oxide, lansoprazole sulfone N-oxide, lansoprazole sulfide, lansoprazole sulfone and N-aralkyl lansoprazole. The present work describes the synthesis and characterization of these impurities.

Keywords:

• HR-MS
• impurities
• lansoprazole
• spectral characterization
• synthesis

ACKNOWLEDGMENTS

The authors are grateful to colleagues in the Analytical Research Department of Integrated Product Development Operations, Discovery Research, and the management of Dr. Reddy's Laboratories Ltd. for providing the necessary support.