Published Paper Details:

Amlodipine, one of the most prescribed medications that act as calcium channel blockers, is found to exist as a racemic mixture. The (S)-enantiomer is clinically more beneficial when compared to its (R)- counterpart, warranting the chiral resolution of amlodipine enantiomers to enhance drug safety and efficacy. This review covers the latest developments in the synthesis of amlodipine derivatives, their chiral resolution by o,o-di-p-toluoyl-D-tartrate resolving agent, and the subsequent method development and validation by high-performance liquid chromatography (HPLC). The efficiency of enantioseparation by different methods, such as diastereomeric salt formation, capillary electrochromatography, and solid-phase extraction by bonded ionic liquids, is considered. Also discussed is the ICH-guided HPLC method validation for precise determination of the degree of enantiomeric excess. This review discusses the limited developments in chiral resolution methods that integrate automation and AI in the development of the chromatographic methods for pharmaceutical analysis to improve accuracy and sustainability.