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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Review Article

A Complete Roadmap of Analytical Quality by Design in Various Analytical Techniques

Author(s): Mohana Krishnan Santhanam, Nalini Calamur Nagarajan*, Poorna Basuri Ponraj and Mohamed Sameer Mohamed Hilurudeen

Volume 19, Issue 3, 2023

Published on: 14 February, 2023

Page: [184 - 215] Pages: 32

DOI: 10.2174/1573412919666230118105908

Price: $65

Abstract

Background: For the development of robust analytical methods, Analytical-Qualityby- Design (AQbD)-based testing methods have been found to be more suited than other one factorial approaches. By creating a Method Operable Design Space, this strategy selects the optimal method conditions using the appropriate Design of Experiments.

Objective: To impart knowledge to the researchers producing methods using this technique, this review seeks to provide an overview of the Analytical Quality-by-Design technique, experimental designs used, and a survey on methods developed using this technique in various analytical instruments.

Methods: The following parts must typically be accomplished for the method to be developed utilizing the Analytical Quality by Design technique: analytical target profile, scouting and risk assessment, experimental runs, selection of Method Operable Design Region, robustness testing, and validation. To optimize the risk parameters, suitable designs for the experiment were chosen based on the number of variables that needed to be optimized.

Conclusion: By establishing a relationship between the high-risk factors and target profiles utilizing multidimensional design space, robustness and other critical quality attributes in techniques were attained with a minimum of experimental runs, analytical time, and energy. So, it stands to reason that the Analytical Quality by Design technique will soon be widely used and highly advantageous in several industries.

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