DefinePK

Abstract

High-Performance Liquid Chromatography (HPLC) is the predominant method employed for the detection, separation, and quantification of pharmaceuticals. To enhance the methodology, many chromatographic parameters were examined, including sample pre-treatment, mobile phase selection, column selection, and detector selection. This article aims to discuss the processes of method development, optimisation, and validation. The HPLC method is advantageous due to its speed, specificity, accuracy, precision, and ease of automation, making it suitable for analysing most medicines in multicomponent dosage forms. The development and validation of HPLC methods are essential in the discovery, development, and production of novel drugs, as well as in many human and animal investigations. Validation of analytical methods is essential during medication development and production to confirm that these procedures are suitable for their intended purpose. To comply with GMP standards, pharmaceutical industries must establish a comprehensive validation policy outlining the validation process. This article focusses on the optimisation of HPLC conditions.