HPLC for pharmaceuticals Scientists.

In the modern pharmaceutical industry, HPLC is a major analytical tool applied at all stages of drug discovery, development and production. Fast and effective development of rugged analytical HPLC methods is more efﬁciently undertaken with a thorough understanding of HPLC principles, theory and instrumentation. The main focus of this book is reversed-phase analysis of small molecules, although there is some attention given to LC-MS of proteins, LCNMR, ion-exchange, size exclusion, and normal phase chromatography.

The drug discovery and development process has undergone dramatic changes particularly in the last decade. The process continues to evolve in response to new discoveries, new technologies, and increasing demand to get more drugs to the market more efﬁciently. Progress in drug discovery has been fueled by improvements in methodologies and technologies in-cluding automated high performance liquid chromatography (HPLC), fast HPLC, automated method development, HPLCMS (mass spectrometry), HPLC-NMR (nuclear magnetic resonance) and high-throughput puriﬁcation methods.

This book is unique in the sense that it elucidates the role of HPLC throughout the entire drug development process from drug candidate incep-tion to marketed drug product. It is written in a manner that scientists at all levels of experience with HPLC will be able to ﬁnd utility while maintaining a reasonable and manageable volume. The book covers the main theoretical and practical aspects of modern HPLC at a level that is suitable for graduate students and chromatography practitioners in industry. In addition, for the more seasoned chromatographer, a description of the speciﬁcs of HPLC appli-cations at different stages of drug development and the latest advancements

in fast, preparative, chiral and other modern LC techniques are included. The information and discussions in this book are meant to increase the chro-matographer’s awareness of trends in HPLC technology with emphasis on their utilization in the various aspects of drug development. Researchers are provided with the opportunity to better understand the use of HPLC not only in their respective “development silos,” but also throughout their organization. Theoretical background as well as practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided throughout this book.

The contents, format and organization herein were inspired by the HPLC short courses and graduate classes we have taught on separation science to a diverse population of pharmaceutical chemist drawn from all areas of drug development. We have observed a desire for a better understanding of work-ﬂows in the various areas of drug development and how HPLC is integrated and embedded into these processes. The book is formatted to address the major functions and tasks in which HPLC is applied.

Even though, there is no “cookbook” for HPLC method development this book provides several strategies that the reader could use when presented with a particular situation. These strategies could be stored as tools in the scientists’ “method development arsenal,” and drawn from when needed to tackle a particular separation. Moreover, some novel approaches for imple-menting HPLC, fast HPLC, and hyphenated HPLC techniques towards phar-maceutical analysis are discussed. This book has the potential to serve as a useful resource for the chromatographic community. It can be used as a hand-book for the novice as well as the more experienced pharmaceutical chemist who utilizes HPLC as an analytical tool to solve challenging problems regu-larly in the pharmaceutical industry.

The completion of this book could not have been possible without the help, inspiration and encouragement from many people.We are very grateful to our families for their understanding and support throughout the entire process of writing and editing. Also, we would like to thank our colleagues, students, friends, and peers for their helpful discussions and contributions to this work. Of special note, we would like to thank Alan Jones, Alexey Makarov, Evan O’Neill, Li Pan, Rajinder Singh, Fred Chan and Richard Vivilecchia. We express our special gratitude to Dr. Harold McNair for his kind support, guid-ance and mentorship over the years and his continued inspiration in our on-going endeavors. We would also like to give special thanks to our wives, Ginevra LoBrutto and Irina Kazakevich, for all their support, patience, under-standing and encouragement. They have been an integral factor in allowing us to accomplish this contribution to the chromatographic and pharmaceutical community. Also, we would like to acknowledge all contributing authors who have done an excellent job in writing their respective chapters, thus allowing for facile integration of their topics into the framework of this book. We really

enjoyed the many fruitful discussions with the contributors and duly acknowl-edge their dedication, efforts and commitment to this work.This has been truly a team effort and we believe the chromatographic community will appreciate the contents and discussions provided within this book.

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