Stability Evaluation of Acetylsalicylic Acid in Commercial Aspirin Tablets under Different Storage Conditions

Abstract

This study evaluated the stability of acetylsalicylic acid (ASA) in commercial Aspirin Protect 100 mg tablets under eight different storage conditions, including varying exposure to moisture, light, and temperature, with a focus on tablets stored in dosette boxes. Acid-base titration methods were used to assess ASA degradation and stability. Elevated moisture had the greatest impact on ASA stability, significantly reducing recovery factors to 85.38% and 81.10% under high humidity, while temperature influenced ASA stability, with notable deviations from control values at temperatures above 25°C (13.26% and 7.16% for two methods). Although storage at 18–25°C yielded acceptable results, reduced temperatures (<8°C) provided better stability. Direct sunlight exposure caused further degradation, reducing recovery values to as low as 82.5% and increasing deviations from control (-10.82% to -16.77%). Hydrolysis, exacerbated by environmental factors, was identified as the primary degradation pathway, leading to the formation of salicylic acid and acetic acid. Samples stored in under recommended conditions had the best stability, with recovery factors meeting pharmacopoeia standards (101.08% and 99.16% of labelled content). These findings underscore the importance of proper storage practices for ASA tablets to maintain their quality, safety, and therapeutic efficacy. While repackaging tablets into dosette boxes may improve compliance, it can compromise stability, highlighting the need for stricter storage guidelines to ensure optimal patient outcomes.