“A CRITICAL REVIEW OF ANALYTICAL STRATEGIES FOR LISDEXAMFETAMINE DEMESYLATE AND ITS IMPURITY PROFILING”

Lisdexamfetamine dimesylate, a therapeutically significant prodrug of dextroamphetamine, is widely used in the management of attention-deficit/hyperactivity disorder (ADHD) and binge eating disorder (BED). Due to its clinical relevance and stringent regulatory requirements, the development and application of precise analytical methods are critical to ensuring the drug's quality, safety, and therapeutic effectiveness. This review offers an in-depth evaluation of contemporary analytical techniques used for the detection and quantification of lisdexamfetamine dimesylate in different pharmaceutical and biological matrices. Methods such as high-performance liquid chromatography (HPLC), liquid chromatography–mass spectrometry (LC-MS), capillary electrophoresis, and UV-visible spectrophotometry are assessed for their accuracy, selectivity, and practicality in quality control settings. Particular attention is given to impurity profiling, focusing on the identification, structural elucidation, and measurement of both process-related and degradation impurities in accordance with ICH standards. Additionally, the review explores formulation strategies aimed at enhancing the drug’s stability and controlled release, including the role of excipients and delivery systems. Overall, this work synthesizes recent progress and ongoing challenges in the analytical and formulation aspects of lisdexamfetamine, providing valuable insights for pharmaceutical scientists and quality assurance professionals.