International Journal of Drug Formulation, Development & Research

Authors:-Deepti Gusain, Kavya Thakur

Abstract:-High-Performance Liquid Chromatography (HPLC) stands as the predominant separation technique for the detection, separation, and quantification of drugs. The versatility of HPLC makes it especially effective for analyzing multi-component dosage forms, owing to its advantages such as speed, specificity, accuracy, precision, and ease of automation. The application of HPLC extends to pivotal roles in the discovery, development, and manufacturing of pharmaceutical drugs, as well as in various studies related to both human and animal subjects. This review provides insights into the different stages involved in the development and validation of HPLC methods. The validation process, aligned with ICH guidelines, encompasses key performance characteristics including accuracy, precision, specificity, linearity, range, limit of detection, limit of quantification, robustness, and system suitability testing.

Keywords:-Pharmaceutical drugs, HPLC (high pressure liquid chromatography) method development, validation.