Synthesis and Spectral Characterization of Related Substances of Lacidipine, an Antihypertensive Drug

Abstract

Five related substances (impurities) were detected in lacidipine bulk drug substance by a simple high-performance liquid chromatographic method (HPLC) and were identified by liquid chromatography–mass spectrometry (LC-MS). These related substances were independently synthesized, characterized, and co-injected with the sample containing impurities.

Keywords:

• Antihypertensive drug
• lacidipine
• related substances
• spectral characterization
• synthesis

ACKNOWLEDGMENTS

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

Notes

DRL Communication No. IPDO-IPM-00147.