Abstract

REVIEW ON ANALYTICAL METHODS DEVELOPMENT BY QBD APPROACH

Neel S. Rathod*, Suraj Singh, Muhammed Azhar Khan, Mitali Dalwadi, Dr. Chainesh Shah and Dr. Umesh Upadhyay

ABSTRACT

The Analytical Quality by Design (AQbD) construct, an extension of QbD, that was introduced in 2004 by the U.S. Food and Drug Administration (FDA) and approved in 2005 by the International Conference on Harmonization (ICH). AQbD could be a systematic approach to methodology development, dominant all stages of the analytical procedure life cycle. AQbD could be a systematic. It includes a definition of the analytical target profile (ATP), identification of vital methodology parameters or factors, and choice of vital methodology attributes (CMAs) or responses. Screening and response-surface experimental designs permit the popularity of serious factors and their improvement by applied math analysis. The factor− response relationship is delineate by a mathematical model, that is ready to predict the optimum response. Variable mixtures of things fulfilling the CMA necessities square measure conferred within the design house or methodology operable design region (MODR), wherever strong methodology performance is ensured. Here by victimization the instance of 2 medication ie. Perindopril & Quercetin Dihydrate we have a tendency to use the Analytical QbD-based HPLC methodology Development for estimation of following medication. For estimation of Quercetin Dihydrate & Perindopril the standard target methodology profile (QTMP) was outlined and vital analytical attributes (CAAs) earmarked. Vital methodology Parameters were evaluated by applying {the design of experiment (DoE) principles and lustiness of the tactic was established by proposing operation design house. Hence, this methodology is appropriate for stability testing of the drug product in internal control laboratories.

Keywords: AQbD, liquid chromatography, DoE, analytical method optimization, FDA, CMA, MODR, QTMP.