Forced degradation study (FDS) is an emerging trend, requisite to be performed and reported while filing abbreviated new drug application (ANDA) and investigational new drug application (IND) application. Modern analytical instruments like HPLC, UPLC, and LC-MS etc. are commonly used throughout the intact study. These methods are more specific, accurate but also costly and time consuming. Optimization of stress conditions is a critical part of study as standard values are not revealed by regulatory authorities. The objective of this work is to explore role of UV spectrophotometer in FDS and to overcome above problems. In this study, FDS of Gallic acid has been carried out using UV spectrophotometer. Gallic acid was exposed to different stress conditions like acidic and alkaline hydrolysis, oxidation, dry heat and photolytic degradation. UV spectrum of sample subjected to stress conditions was recorded and compared with standard spectrum. It was found that Gallic acid has undergone degradation in acidic (HCl), alkaline (NaOH) and oxidative media (H2O2). However, it was found stable at thermal and photolytic stress conditions. The present study explains usefulness of UV-Visible spectrophotometer in FDS which helps to save time and expenditure required for study.
