Analytical method development and validation play a major role in the discovery, development and manufacturing of pharmaceuticals. The official test method that results from these processes is used by quality control laboratories to ensure the identity, purity, potency and performance of drug product quality, essential for drug safety and efficiency. Method development is a formalized process by which a set of separation criteria are determined with a defined set of parameters such that the same separation profile is achieved. The process of method development can be quantitative or qualitative.