Validation of forced degradation and stability-indicating studies of a nanoformulation using Spectroscopic technique

Analytical method validation plays a vital role in pharmaceutical development by ensuring the accuracy, precision, and reliability of results obtained for drug substances and nanoformulations. This study presents the development and validation of a simple, sensitive, and robust UV spectrophotometric method for the quantitative estimation of drugs in nanoformulations in accordance with International Council for Harmonisation guidelines. The method was systematically evaluated for specificity, linearity, accuracy, precision, range, robustness, and limits of detection and quantitation to confirm its suitability for routine application. Forced degradation studies were performed under hydrolytic, oxidative, photolytic, and thermal stress conditions to assess the stability-indicating capability of the method and to elucidate potential degradation pathways. Additionally, stability studies were conducted to investigate the effects of storage conditions, pH variations, dilution, and temperature on the stability of the nanoformulation. Statistical analysis supported the consistency and reproducibility of the experimental data. The validated method demonstrated reliable performance for bulk drug and nanoformulation analysis. Overall, the proposed approach provides an efficient and cost-effective strategy for analytical method validation and can be successfully applied in routine quality control to ensure the quality, stability, and safety of pharmaceutical nanoformulations.