A Review: Analytical method development using QbD Tools
Rekha Bhalerao , Ashish Phuge , Vijaya Barge
1 Research Scholar , 2 Associate Professor , 2 Department of Pharmaceutical Chemistry 1 PDEA’s Seth Govind Raghunath Sable College of Pharmacy, Saswad, Pune - 412301, Maharashtra, India. 2 PDEA'S Shankarrao Ursal College of Pharmaceutical Sciences & Research Center, Kharadi, Pune -14, Maharashtra, India.
Corresponding Author: Vijaya Barge
E-mail: godse _vijaya@rediffmail.com
Submission: 01.11.2018 Acceptance: 02.12.2018 Publication: 15.02.2019
https://www.doi.org/10.63778/PDEASIJRAAS-ARJCPL/2019_21525
Abstract: In a QbD approach, the impact and interactions between critical method variables are understood using a Design of Experiments approach. QbD tools such as risk assessment and design of experiments incorporate better quality into the analytical method, facilitate prior understanding and identification of variables affecting method performance. The main objective of the present review article to describe different tools involved in method development by QbD approach for an analytical method development. The objective of this review article is to provide a brief idea about quality risk management, Analytical Target Profile, Design of Experiment in method development.