Analytical Method Development for Drugs and Impurities Degradation Using High-Performance Liquid Chromatography (HPLC)

Abstract- High Performance Liquid Chromatography (HPLC) is a powerful technique which helps in development andvalidation of analytical methods for drug analysis, including degradation studies. The paper focuses on the application ofHPLC for analysis of drug impurities and degradation products. The experimental result demonstrates the robustness,accuracy, sensitivity of HPLC method for detection of degraded products and identifying impurities in pharmaceuticaldrugs. The method was validated according to ICH guidelines for precision, linearity, specificity, accuracy, and robustness.The study concludes on the method being suitable for regulatory compliance and quality assurance in the pharmaceuticalindustry.