Comprehensive Stability Evaluation and Shelf-life Determination of Escitalopram and Clonazepam Fixed- Dose Combination Tablets
Year: 2025
Type: article
Abstract: 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 (40°C/75% RH), intermediate (30°C/65% RH), and long-term (25°C/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.
Author: Dr. Shailesh Shaarma
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W4412868621