HPLC for Pharmaceutical Scientists

1. Edition January 2007
1136 Pages, Hardcover
Wiley & Sons Ltd
Short Description
HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry.
In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. 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.
This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development.
The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.
Comprehensive coverage of modern HPLC theory, methodologies, and applications
This guide is a valuable resource for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. A unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry is provided throughout the book.
* In-depth discussions of retention processes, modern HPLC separation theory, and properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation
* Practical and pragmatic approaches and numerous examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are given
* This book elucidates the role of HPLC throughout the entire drug development process, from drug candidate inception to marketed drug product, and gives detailed specifics of HPLC application at each stage of drug development
* The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS-small molecules and proteins, LC-NMR, Preparative HPLC, High temperature HPLC, Chiral HPLC, and Fast LC) are discussed
Authoritative and up to date, HPLC for Pharmaceutical Scientists is an ideal reference for pharmaceutical researchers working with HPLC, as well as for graduate students in analytical chemistry/biochemistry and pharmaceutical analysis programs.
CONTRIBUTORS.
PART I HPLC THEORY AND PRACTICE.
1 Introduction (Yuri Kazakevich and Rosario LoBrutto).
2 HPLC Theory (Yuri Kazakevich).
3 Stationary Phases (Yuri Kazakevich and Rosario LoBrutto).
4 Reversed-Phase HPLC (Rosario LoBrutto and Yuri Kazakevich).
5 Normal-Phase HPLC (Yong Liu and Anant Vailaya).
6 Size-Exclusion Chromatography (Yuri Kazakevich and Rosario LoBrutto).
7 LC/MS: Theory, Instrumentation, and Applications to Small Molecules (Guodong Chen, Li-Kang Zhang, and Birendra N. Pramanik).
8 Method Development (Rosario LoBrutto).
9 Method Validation (Rosario LoBrutto and Tarun Patel).
10 Computer-Assisted HPLC and Knowledge Management (Yuri Kazakevich, Michael McBrien, and Rosario LoBrutto).
PART II HPLC IN THE PHARMACEUTICAL INDUSTRY.
11 The Expanding Role of HPLC in Drug Discovery (Daniel B. Kassel).
12 Role of HPLC in Preformulation (Irina Kazakevich).
13 The Role of Liquid Chromatography-Mass Spectrometry in Pharmacokinetics and Drug Metabolism (Ray Bakhtiar, Tapan K. Majumdar, and Francis L. S. Tse).
14 Role of HPLC in Process Development (Richard Thompson and Rosario LoBrutto).
15 Role of HPLC During Formulation Development (Tarun S. Patel and Rosario LoBrutto).
16 The Role of HPLC in Technical Transfer and Manufacturing (Joseph Etse).
PART III HYPHENATED TECHNIQUES AND SPECIALIZED HPLC SEPARATIONS.
17 Development of Fast HPLC Methods (Anton D. Jerkovich and Richard V. Vivilecchia).
18 Temperature as a Variable in Pharmaceutical Applications (Roger M. Smith).
19 LC/MS Analysis of Proteins and Peptides in Drug Discovery (Guodong Chen, Yan-Hui Liu, and Birendra N. Pramanik).
20 LC-NMR Overview and Pharmaceutical Applications (Maria Victoria Silva Elipe).
21 Trends in Preparative HPLC (Ernst Kuesters).
22 Chiral Separations (Nelu Grinberg, Thomas Burakowski, and Apryll M. Stalcup).
CHEMICAL AND DRUG COMPOUND INDEX.
SUBJECT INDEX.
Dr. ROSARIO LOBRUTTO has over thirteen years of experience in the pharmaceutical industry working both with drug substances and drug products. He is a Group Head in the Pharmaceutical and Analytical Development Department at Novartis Pharmaceuticals Corporation managing multiple early to late phase projects for both small drug molecules and proteins/peptides and is responsible for teaching in-house HPLC method development training. Dr. LoBrutto is the author of twenty research articles, fifty presentations, and five book chapters in different areas of analytical/physical chemistry and has served as an adjunct professor for seven years. Dr. LoBrutto's main research directions include HPLC retention mechanisms, the influence of mobile phase modifiers on analyte retention and chromatographic figures of merit, and method development strategies for small molecules and proteins/peptides.