Skip to:Content
|
Bottom
Cover image for HPLC for pharmaceutical scientists
Title:
HPLC for pharmaceutical scientists
Publication Information:
Hoboken, NJ : Wiley-Interscience, 2007
ISBN:
9780471681625

Available:*

Library
Item Barcode
Call Number
Material Type
Item Category 1
Status
Searching...
30000010151862 RS189.5.H53 H53 2007 Open Access Book Book
Searching...

On Order

Summary

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 Notes

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.


Table of Contents

Preface
Contributors
Part I HPLC Theory and Practice
1 IntroductionYuri Kazakevich and Rosario LoBrutto
1.1 Chromatography in the Pharmaceutical World
1.2 Chromatographic Process
1.3 Classification
1.4 History of Discovery and Early Development (1903-1933)
1.5 General Separation Process
1.6 Types of HPLC
1.7 HPLC Descriptors (Vr, k, N, etc.)
2 HPLC TheoryYuri Kazakevich
2.1 Introduction
2.2 Basic Chromatographic Descriptors
2.3 Efficiency
2.4 Resolution
2.5 HPLC Retention
2.6 Retention Mechanism
2.7 General Column Mass Balance
2.8 Partitioning Model
2.9 Adsorption Model
2.10 Total and Excess Adsorption
2.11 Mass Balance in Adsorption Model
2.12 Adsorption of the Eluent Components
2.13 Void Volume Considerations
2.14 Thermodynamic Relationships
2.15 Adsorption-Partitioning Retention Mechanism
2.16 Secondary Equilibria
2.17 Gradient Elution Principles
2.18 Types of Analyte Interactions with the Stationary Phase
2.19 Conclusion
3 Stationary PhasesYuri Kazakevich and Rosario LoBrutto
3.1 Introduction
3.2 Type of Packing Material (Porous, Nonporous, Monolithic)
3.3 Base Material (Silica, Zirconia, Alumina, Polymers)
3.4 Geometry
3.5 Adsorbent Surface Chemistry
3.6 Surface of Chemically Modified Material
3.7 Polymer-Based Adsorbents
3.8 Stationary Phases for Chiral Separations
3.9 Columns
4 Reversed-Phase HPLCRosario LoBrutto and Yuri Kazakevich
4.1 Introduction
4.2 Retention in Reversed-Phase HPLC
4.3 Stationary Phases for RPLC
4.4 Mobile Phases for RPLC
4.5 pH Effect on HPLC Separations
4.6 Effect of Organic Eluent Composition on Analyte Ionization
4.7 Synergistic Effect of pH, Organic Eluent, and Temperature on Ionizable Analyte Retention and Selectivity
4.8 Examples of Applying pH Shift and Analyte pKa Shift Rules
4.9 Effect of Temperature on Analyte Ionization
4.10 Ion-Interaction Chromatography
4.11 Concluding Remarks
5 Normal-Phase HPLCYong Liu and Anant Vailaya
5.1 Introduction
5.2 Theory of Retention in Normal-Phase Chromatography
5.3 Effect of Mobile Phase on Retention
5.4 Selectivity
5.5 Applications
5.6 Conclusions
6 Size-Exclusion ChromatographyYuri Kazakevich and Rosario LoBrutto
6.1 Separation of the Analyte Molecules by Their Size
6.2 Molecular Size and Molecular Weight
6.3 Separation Mechanism
6.4 Calibration
6.5 Columns
6.6 Molecular Weight Distribution
6.7 Effect of Eluent
6.8 Effect of Temperature
6.9 Detectors
6.10 Solving Mass Balance Issues
6.11 Aqueous SEC Applications
7 LC/MS: Theory, Instrumentation, and Applications to Small MoleculesGuodong Chen and Li-Kang Zhang and Birendra N. Pramanik
7.1 Introduction
7.2 Ionization Methods and LC/MS Interfaces
7.3 Mass Analyzers
7.4 Role of Instrumental Parameters on Ionization Efficiency in LC/MS
7.5 Effect of Mobile-Phase Composition on Ionization Efficiency in LC/MS
7.6 MS Interpretation
7.7 Practical Applications
7.8 Conclusions
8 Method DevelopmentRosario LoBrutto
8.1 Introduction
8.2 Types of Methods
8.3 Defining the Method
8.4 Method Development Considerations
8.5 Method Development Approaches
8.6 Effect of pH on UV Absorbance
8.7 Analyte pKa-From an Analytical Chemist's Perspective
8.8 Reversed-Phase Versus Normal-Phase Separations
8.9 Instrument/System Consi
Go to:Top of Page