Statistical Modelling of Degradation Kinetics and Accelerated Stability Testing for Shelf-Life Prediction of Escitalopram and Clonazepam Tablets

Abstract

This study presents a detailed statistical analysis and kinetic modeling approach applied to stability data of Escitalopram and Clonazepam fixed-dose combination (FDC) tablets. The aim was to elucidate the degradation kinetics, predict shelf-life more accurately using accelerated stability testing, and validate the product's stability under various storage conditions. Data from long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) studies, spanning up to 24 months, were analyzed using regression analysis, ANOVA, and kinetic models. Results consistently indicated that the degradation of both Escitalopram and Clonazepam followed first-order kinetics. The Arrhenius equation was successfully applied to accelerated data to estimate activation energy and predict degradation rates at lower temperatures, confirming a shelf-life of at least 24 months. This research highlights the critical role of robust statistical methods in pharmaceutical stability studies, providing a scientific basis for shelf-life assignment and ensuring drug quality and safety throughout its intended duration.