Review article on High-Performance Liquid Chromatography (HPLC) Method Development and Validation

Abstract

High-Performance Liquid Chromatography (HPLC) is a type of column chromatography that is commonly used in biochemistry and analysis to separate, identify, and quantify active chemicals. HPLC is the most often used separation technology for detecting, separating, and quantifying the drug. HPLC technique development and validation serve critical roles in novel drug discovery, development, and manufacturing, as well as a variety of other human and animal investigations. This review discusses the many processes involved in developing and validating an HPLC technique. The creation of an HPLC technique is influenced by the chemical structure of the molecules, the synthetic pathway, solubility, polarity, pH and pKa values, and the activity of functional groups, among other factors. Accuracy, accuracy, specificity, linearity, range, limit of detection, the limit of quantification, robustness, and system suitability testing are all included in the validation of an HPLC technique according to ICH Guidelines.