A comprehensive review on QbD driven analytical procedures developed for the analysis of various drugs

Abstract

Quality has been a prime priority for the pharmaceutical sector with the development of recommendations by regulatory organizations like ICH. Concepts of ICH Q8 to Q10 are the foundation of the QbD methodology, a systematic approach to pharmaceutical development. Pharma industries have adopted the QbD approach to support product quality during manufacturing and to improve robust manufacturing processes. QbD adoption in analytical procedure development is AQbD, Analytical Quality by Design. It aids in reliable, economical analytical procedure development and also facilitates regulatory flexibility. This review illustrates the detailed aspects with relevant examples in each step of AQbD and DoE techniques applied to various analytical techniques for analytical procedure development for the determination of medicinal compounds. The overview of techniques created using AQbD contributes to the direction in this field of study.

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Keywords:

• AQbD
• analytical quality by design
• design of experiments
• DoE
• method development
• Analytical Target Profile
• QbD
• quality by design
• quality risk management

JEL CLASSIFICATION CODES:

• HPLC-UV/VIS
• HPLC-DAD
• HPTLC
• LC-MS

Acknowledgments

The authors would like to thank Dr. C. Gangi Reddy, Founder, Annamacharya Educational Trust, Rajampet, India, and Dr. D. Swarnalatha, Principal, Annamacharya College of Pharmacy, Rajampet, India, for providing the necessary facilities in bringing this review.

Author contributions

Galla Rajitha conceived and designed the work. Aggarapu Susmitha collected the data and performed the analysis. Gireesh Kumar Eri contributed data. The manuscript was written through the contributions of all authors. All authors have given approval to the final version of the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).