The quote of Charles Darwin “It’s neither the strongest of the species, nor the most intelligent, but the those that are most responsive to change that survive” surely applicable to Quality by Design (QbD) approach which means that in this era of competition where quality has been given prime importance one has to change the frizzed approach of analytical development to develop a product which is free from deficiencies. In the present review concept, call for i.e. need and constraints of analytical quality by design are discussed. In detail explanation of elements of AQbD i.e. Analytical Target profile, design of experiments and design space, method operable design region (MODR), risk assessment and method development are given. Applications of analytical quality by design (AQbD) in determination of impurity, in screening of column used in chromatography, in development of HPLC method for drug substances, in capillary electrophoresis, in stability studies, in UHPLC, in LC-MS method development, bio analytical method development and in dissolution studies is explained in detail by referencing examples.
Loading....