CUTTING-EDGE DEVELOPMENTS IN HPLC FOR IDENTIFYING PROCESS IMPURITIES: A REVIEW ON METHOD OPTIMIZATION AND VALIDATION

High-Performance Liquid Chromatography (HPLC) is a widely utilized column chromatography technique in biochemistry and analytical sciences for the separation, identification, and quantification of active compounds. Renowned as a leading separation technology, HPLC plays a pivotal role in detecting, separating, and quantifying pharmaceutical drugs. The development and validation of HPLC methods are essential in novel drug discovery, development, manufacturing, and various human and animal studies. This review highlights the comprehensive processes involved in the development and validation of HPLC methods. Method development is influenced by factors such as the chemical structure of molecules, synthetic pathways, solubility, polarity, pH, pKa values, and the activity of functional groups. Validation, as per ICH Guidelines, encompasses key parameters including accuracy, precision, specificity, linearity, range, limits of detection and quantification, robustness, and system suitability testing.