抽象的

Analytical Quality by Design: an emerging tool for Regulatory Flexibility in Chromatography

Bikash Ranjan Jena

 It is a well-known fact that chromatography is method of separation of mixture of drug substance through instruments like HPLC, UHPLC, UPLC and hyphenated techniques such as LC-MS, LC-NMR, etc. The major intent of chromatography is to find out the occurrence or measurement of the relative proportions of analytes in a mixture. But the modern scientific technology equipped with implementation of Quality by Design (QbD) is a systematic approach for robust product development with less span of time as per regulatory compliance and ICH recommended quality guidelines. This QbD enabled holistic approach especially to the analytical development is well-known as Analytical Quality by design (AQbD), which is recognized as a rational and rapid analytical methodology, that can minimize more solvent consumption, reagents, additional resources during chromatographic analysis. In this current review, an attempt has been made to elucidate the applications of Design of Experiment (DoE) to the chromatographic development through its modern statistical software’s which enhances for regulatory flexibility and homogenous product development.