Technology Development for the Synthesis of S-Amlodipine Nicotinate Drug Substance

Abstract

Technology for the synthesis of S-amlodipine nicotinate drug substance was developed based on an acceptable method of effective separation of the amlodipine optical isomers. A literature review suggested that the most promising methods employed 2-propanol (pure or with small additions of cosolvents) as the main solvent. However, experiments showed that the optimum solvent was DMSO. The proposed synthesis of S-amlodipine nicotinate drug substance was confirmed to be stable and reproducible. Standardization methods were developed.