Affiliation:
1. Department of Pharmaceutical Analysis, C.L. Baid Metha College of Pharmacy, Rajiv Gandhi Salai, Thoraipakkam,
Chennai-600097, Tamil Nadu, India
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.
Method:
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.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics
Reference203 articles.
1. Juran J.M.; Juran on quality by design: The new steps for planning quality into goods and services. Simon and Schuster 1992
2. Snyder L.R.; Efficient HPLC method development and personal reflections. LC GC Eur 2012,25(8),437-444
3. Schmidt A.H.; Molnár I.; Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations. J Pharm Biomed Anal 2013,78-79,65-74
4. Kormany R.; Rieger H.J.; Molnar I.; Application of quality by design principles to a pharmaceutical sample using uhplc method development with modeling technologies. Chromatogr Online 2013,31(4),20-27
5. García-Álvarez-Coque M.C.; Torres-Lapasió J.R.; Baeza-Baeza J.J.; Models and objective functions for the optimisation of selectivity in reversed-phase liquid chromatography. Anal Chim Acta 2006,579(2),125-145