About the Book:

The Analytical Procedure Development by Quality by Design is an essential resource for anyone navigating the complex world of analytical chemistry. This comprehensive guide not only covers the fundamentals of analytical procedure development but also introduces the innovative principles of Quality by Design (QbD), revolutionizing the field.

From classical to advanced techniques, this book explores a wide range of methodologies, providing readers with a thorough understanding of the subject. It delves into both Minimal and Enhanced approaches, giving readers insight into different strategies for analytical procedure development.

One of the standout features of this book is its in-depth analysis of AQbD components, principles, and regulatory perspectives. With a chapter dedicated to Design of Experiments (DoE), readers will gain practical insights into how to effectively implement this method in their work.

Furthermore, this book offers a detailed roadmap for QbD principles and analytical development, making it an invaluable resource for those looking to apply these concepts in their own research and projects. The book also includes practical examples in UV-Visible spectrophotometric, HPLC, GC, HPTLC, and bioanalytical methods, allowing readers to see these principles in action.

With its reader-friendly elements, this book caters to a diverse audience, including students, researchers, and professionals in analytical chemistry. It provides comprehensive guidance and serves as a reliable companion for analytical procedure development and QbD understanding.

Contents: 

1.     Analytical Procedure Development

2.    Analytical Quality by Design (AQbD)

3.    Design of Experiments (DoE)

4.    Implementation of QbD in Analytical Procedure Development

5.    AQbD for UV-Visible spectrophotometric method development

6.    AQbD for HPLC Method Development

7.    AQbD for GC Method Development

8.       AQbD for HPTLC Method Development

9.       QbD for Bio-analytical Method Development

About the Authors:

Galla Rajitha, currently holding the position of Professor at the Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati, boasts an extensive academic and research profile. Serving in various capacities, including Convenor of the Institution Innovation Council, Biological Scientist and Chairperson of the Institutional Animal Ethics Committee, and Director of the Centre for University Community Engagement at SPMVV, she has been a dedicated contributor to pharmaceutical education since December 1996. With a Ph.D. awarded in 2008 from SPMVV, Tirupati, she has accumulated a wealth of teaching experience. Prof. Rajitha has successfully guided Ph.D., M.Pharm, and B.Pharm students in their project work, demonstrating her commitment to research mentorship. Her research endeavours have secured grants of Rs. 13,40,300/- from the University Grants Commission, focusing on the synthesis and biological evaluation of various compounds for anti-inflammatory and antioxidant activities. Actively participating in academic events, she has attended numerous orientation/refresher courses, organized seminars, and served on the editorial boards of prestigious pharmaceutical science journals. Prof. Rajitha's areas of expertise include the synthesis of heterocyclic compounds and method development/validation of novel drugs. With more than 50 publications, 1 handbook, and 5 book chapters, she has made significant contributions to the field. Her involvement in various professional societies, memberships, and roles in extension activities and administrative positions further underscore her holistic engagement in the academic community. Recognized with Honors and Awards, including the State Teacher Award, from the Govt. of A. P.,

Dr. V. Ramalinga Swamy Memorial Award – 2020 in Medical Science from Science City of Andhra Pradesh, Govt. of A.P. and elected as Fellow of Andhra Pradesh Akademi of Sciences, Amaravati, she continues to be a distinguished figure in pharmaceutical education and research.

Aggarapu Susmitha is currently serving as an Associate Professor at Annamacharya College of Pharmacy (Autonomous), Rajampet. She completed her B Pharmacy from Sri Padmavathi School of Pharmacy, Tirupathi, and her M Pharmacy from PRRM College of Pharmacy, Kadapa. Currently pursuing a Ph.D. at SPMVV, Tirupathi. She has been teaching since October, 2013. She has made significant contributions to scholarly publications, with 13 articles in national and international journals. Noteworthy achievements include winning the First Prize in the Pharma Women's League-2023 competition for "Innovations & Entrepreneurship (Zonal Level)" and securing the 3rd Rank in APRCET-2021. She also received the SWAYAM ARPIT Online-Certification with Grade A for the course "Online Refresher Course in Pharmacy for Higher Education". She qualified in GPAT-2011. She is also a Life Member of the Indian Pharmacy Graduates Association. She actively participated in 20 QIPs and FDPs and attended 50 seminars, conferences, workshops, and webinars. She has guided theses at both undergraduate and postgraduate levels, with 10 at the UG level and 5 at the PG level. She has also contributed to literature with the publication of two books and holds one published patent. Her dedication to education and research, along with her achievements in competitions, highlights her impactful role in pharmaceutical academia.

Gireesh Kumar Eri is currently serving as an Associate Professor and the Controller of Examinations at Annamacharya College of Pharmacy (Autonomous), Rajampet. He completed his B Pharmacy at Sree Vidyanikethan College of Pharmacy, Tirupati, and his M Pharmacy at the Centre for Pharmaceutical Sciences, IST, JNTUH, Hyderabad. Currently pursuing a Ph.D. at JNTUA, he has been actively involved in teaching since October 2010, contributing to 16 publications in various national and international journals. Among his notable achievements, he excelled in NPTEL Online-Certification courses, securing the top position. He is also recognized as a Certified Trainer for Quality Control Chemist. Moreover, his accomplishments extend to winning awards, including the Best Paper for Poster Presentation at an International Conference organized by Karpagam College of Pharmacy, Coimbatore, the Best Poster Presentation at the 68th IPC held at AUCPS, Andhra University, Visakhapatnam. Beyond his academic achievements, he is an active member of professional organizations such as APTI and IPGA. His engagement in various seminars and conferences is further highlighted by his role as an Organizing Member. Dedicated to continuous learning, he has attended 25 QIPs and FDPs and participated in 50 seminars, conferences, workshops, and webinars. Additionally, he has guided topics for 20 seminars and conferences and mentored 13 theses at the undergraduate level and 18 at the postgraduate level. His contributions extend to the publication of two books and the filing of three patents, showcasing his diverse and impactful contributions to education and research.