COMPREHENSIVE STABILITY EVALUATION AND SHELF-LIFE DETERMINATION OF ESCITALOPRAM AND CLONAZEPAM FIXED- DOSE COMBINATION TABLETS

This study comprehensively evaluated the physical and chemical stability of fixed-dose combination (FDC) tablets containing Escitalopram and Clonazepam, crucial for treating psychiatric disorders, under various International Conference on Harmonization (ICH) compliant storage conditions.The research aimed to establish the shelf-life and understand the degradation profiles of these sensitive drugs.Three batches of FDC tablets were subjected to accelerated (40C/75% RH), intermediate (30C/65% RH), and long-term (25C/60% RH) stability testing for up to 24 months.Physicochemical properties, drug content, impurity levels, and dissolution profiles were monitored using validated analytical techniques, including High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry/ Mass Spectrometry (LC-MS/MS).The results confirmed that the tablets maintained their physical and chemical stability, meeting all regulatory specifications throughout the study period.Degradation kinetics followed first-order kinetics, and the study successfully established a shelf-life of at least 24 months under the tested conditions.This research provides critical data for regulatory approval, manufacturing quality assurance, and safe patient use of Escitalopram and Clonazepam FDC tablets.