Strategic approach for HPLC Method Development and Validation: Review

Abstract

High performance liquid chromatography (HPLC) is an analytical technique which is adept to separate, detect and quantify numerous pharmaceuticals and their related degradants. It is also used to identify and measure synthetic drugs, to minimise other impurities at the time of separation, and to separate manufactured medicines from drug-related contaminants. To improve the procedure, a number of chromatographic parameters were assessed. It is necessary to identify the best mobile phase, column, detector, buffer, wavelength, and gradient for the drug's compatibility and stability with degradants and contaminants. This study discusses the significance of RP-HPLC in the development of analytical methods, their techniques, and a brief overview of the key chromatographic parameters that must be tuned for effective method development.