Summary

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.

Author Biography

Dr. YURI KAZAKEVICH is an Associate Professor of Analytical Chemistry at Seton Hall University with thirty years of experience in liquid chromatography. He has over fifteen years of academic research experience in Russia and fifteen years of research, teaching and consulting for major American pharmaceutical companies, which has resulted in numerous papers and four book chapters. The main focus of Dr. Kazakevich's research is in HPLC retention mechanisms and the description of the analyte migration through the column with an emphasis on the influence of adsorbent geometry and surface chemistry. Dr. Kazakevich is the author of Basic Liquid Chromatography, one of the oldest and most complete online instructional resources on HPLC.

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.

Preface
Contributors
HPLC Theory and Practice
Introduction
Chromatography in the Pharmaceutical World
Chromatographic Process
Classification
History of Discovery and Early Development (1903-1933)
General Separation Process
Types of HPLC
HPLC Descriptors (Vr, k, N, etc.)
HPLC Theory
Introduction
Basic Chromatographic Descriptors
Efficiency
Resolution
HPLC Retention
Retention Mechanism
General Column Mass Balance
Partitioning Model
Adsorption Model
Total and Excess Adsorption
Mass Balance in Adsorption Model
Adsorption of the Eluent Components
Void Volume Considerations
Thermodynamic Relationships
Adsorption-Partitioning Retention Mechanism
Secondary Equilibria
Gradient Elution Principles
Types of Analyte Interactions with the Stationary Phase
Conclusion
Stationary Phases
Introduction
Type of Packing Material (Porous, Nonporous, Monolithic)
Base Material (Silica, Zirconia, Alumina, Polymers)
Geometry
Adsorbent Surface Chemistry
Surface of Chemically Modified Material
Polymer-Based Adsorbents
Stationary Phases for Chiral Separations
Columns
Reversed-Phase HPLC
Introduction
Retention in Reversed-Phase HPLC
Stationary Phases for RPLC
Mobile Phases for RPLC
pH Effect on HPLC Separations
Effect of Organic Eluent Composition on Analyte Ionization
Synergistic Effect of pH, Organic Eluent, and Temperature on Ionizable Analyte Retention and Selectivity
Examples of Applying pH Shift and Analyte pKa Shift Rules
Effect of Temperature on Analyte Ionization
Ion-Interaction Chromatography
Concluding Remarks
Normal-Phase HPLC
Introduction
Theory of Retention in Normal-Phase Chromatography
Effect of Mobile Phase on Retention
Selectivity
Applications
Conclusions
Size-Exclusion Chromatography
Separation of the Analyte Molecules by Their Size
Molecular Size and Molecular Weight
Separation Mechanism
Calibration
Columns
Molecular Weight Distribution
Effect of Eluent
Effect of Temperature
Detectors
Solving Mass Balance Issues
Aqueous SEC Applications
LC/MS: Theory, Instrumentation, and Applications to Small Molecules
Introduction
Ionization Methods and LC/MS Interfaces
Mass Analyzers
Role of Instrumental Parameters on Ionization Efficiency in LC/MS
Effect of Mobile-Phase Composition on Ionization Efficiency in LC/MS
MS Interpretation
Practical Applications
Conclusions
Method Development
Introduction
Types of Methods
Defining the Method
Method Development Considerations
Method Development Approaches
Effect of pH on UV Absorbance
Analyte pKa-From an Analytical Chemist's Perspective
Reversed-Phase Versus Normal-Phase Separations
Instrument/System Consi
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