Published Paper Details:

Ensuring pharmaceutical product quality and safety requires robust analytical methodologies throughout the drug development and manufacturing processes. Ultraviolet-visible (UV-Vis) spectroscopy has emerged as a fundamental analytical technique in pharmaceutical laboratories due to its operational simplicity, high sensitivity, cost-effectiveness, and regulatory acceptance. This review provides a comprehensive examination of UV spectroscopic applications specifically focused on pharmaceutical quality control and impurity detection. The fundamental principles of light absorption, the Beer-Lambert law, and electronic transitions in molecules are discussed in detail. Various pharmaceutical applications including compound identification, quantitative assay of active pharmaceutical ingredients, detection and quantification of impurities, analysis of degradation products, and dissolution testing are extensively reviewed. Method validation approaches aligned with International Conference on Harmonization (ICH) guidelines are elaborated, incorporating specificity, linearity, accuracy, precision, range, and robustness parameters. Regulatory compliance requirements established by major pharmacopeial standards including United States Pharmacopeia (USP), European Pharmacopoeia (EP), and related standards are discussed. The advantages and limitations of UV spectroscopy are critically analyzed, and emerging applications including diode array detection, chemometric integration, and process analytical technology are highlighted. This review demonstrates the continued significance of UV spectroscopy in pharmaceutical quality assurance and its substantial role in contemporary pharmaceutical analysis.