Review on Development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography

RP-HPLC is the most, sensitive, universal analytical procedure. It is extremely versatile tech where analytes are separated by passes through column of different sized particles. Analytical method development ensures the specific characteristics of the drug substances against the preconceived acceptance criteria, while method meets objectives required at each stage of development of drug which is a continuous process, and should be robust and accessible. Validation of analytical method demonstrates the scientific firmness of measurement or characterization and is required throughout the regulatory submission process and the main purpose of validation of API is to demonstrate that it maintains the desired level of compliance and also suitable for its intended purpose.