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E-grāmata: HPLC Method Development for Pharmaceuticals

Edited by (President, Ahuja Consulting for Water Quality, Calabash, NC, USA), Edited by (Global Analytical Development, Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA)
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HPLC Method Development for PharmaceuticalsPalielināt
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High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective.
HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.

* Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
* Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
* Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Recenzijas

"This book is written with pharmaceutical scientists in mind, regardless of their level of experience with HPLC method development. By extension, it would be valuable for managers and regulators as well. It may also be of value to those managing a lab or research program in the academic setting.

The 18 chapters are written by 35 contributors, mostly from the U.S., with just over half from the pharmaceutical industry. The book is divided into two major sections, one a state-of-the-science review of HPLC and one on the unique needs in a pharmaceutical setting. This latter section is what makes the book most useful to the intended audience. It addresses topics such as method development for each phase in the drug development process, strategies for software/hardware validation, and prevention/troubleshooting problems. There is lots of concern for instrument qualification and validation in meeting regulatory requirements. The role of HPLC in tandem with mass spectrometry and other detection methods for assaying biological samples does not receive nearly as much attention.

Assessment: The book is clearly superior to the many books on HPLC methods development which do not address pharmaceutical issues to any great extent, if at all. There is generous use of figures and tables throughout and very little overlap across chapters. Weighted Numerical Score: 88 - 3 Stars" --Review in Doody's 2008, by Joseph Boullata, PharmD(University of Pennsylvania College of Nursing)

Papildus informācija

A definitive reference source of HPLC method development
Preface xiii
Contributors xv
Overview of HPLC Method Development for Pharmaceuticals
Satinder Ahuja
Introduction
1(1)
Theoretical Considerations
2(1)
HPLC Columns and Column Packings
2(1)
Column Selection
3(1)
Chiral Separations
3(1)
Contemporary HPLC
4(1)
Hyphenated Methods
5(1)
Sample Preparation
5(1)
Instrument Qualification and Software Validation
6(1)
Pharmaceutical Development
6(1)
Drug Discovery
7(1)
Early Phase Method Development
8(1)
Late Phase Development
8(1)
In-Process Testing
9(1)
Method Development for Biomolecules
9(1)
Method Validation
10(1)
Troubleshooting
10(1)
Molecularly Imprinted Polymers
10(3)
References
11(2)
HPLC Theory
Y.V. Kazakevich
Abstract
13(1)
Introduction
13(1)
Basic Chromatographic Descriptors
14(1)
Efficiency
15(5)
Resolution
20(2)
Main Components of the Retention Mechanism
22(2)
General Column Mass Balance
24(3)
Partitioning Model
27(1)
Adsorption Model
28(1)
Void Volume Considerations
29(2)
Thermodynamic Relationships
31(4)
Secondary Equilibria
35(2)
Salt Effect
37(1)
Effect of Different Counteranions
38(2)
Inclusion of Secondary Equilibria in the Mass Balance
40(3)
Conclusions
43(3)
References
43(2)
HPLC Columns and Packings
Uwe D. Neue
Bonnie A. Alden
Edward R. Grover
Eric S. Grumbach
Pamela C. Iraneta
Alberto Mendez
Abstract
45(1)
Introduction
46(1)
Column Chemistry
47(21)
Speed and Resolution
68(9)
Specialty Columns from Nanobore to Preparative Chromatography
77(3)
Summary
80(6)
References
80(5)
Column Characterization and Selection
Dora Visky
Abstract
85(1)
Introduction
86(4)
Characteristics of RP-HPLC Columns and Chromatographic Tests
90(11)
Column Classification and Selection
101(3)
Conclusions
104(8)
Acknowledgment
105(1)
References
105(6)
Chiral Separations
Xiande Wang
Weiyong Li
Henrik Rasmussen
Abstract
111(1)
Introduction
112(3)
Separation of Enantiomers on HPLC Chiral Stationary Phases
115(20)
Practical Guidelines to Chiral HPLC of Pharmaceuticals
135(2)
Conclusions
137(9)
References
138(7)
Contemporary Liquid Chromatographic Systems for Method Development
Michael E. Swartz
Abstract
145(1)
Introduction
146(1)
Traditional Instrumentation for HPLC Method Development
147(6)
Contemporary Method Development Systems
153(16)
Migrating Methods from HPLC to UPLC
169(5)
UPLC Applications in Pharmaceutical Analysis
174(9)
Summary and Conclusions
183(7)
Acknowledgments
184(1)
References
185(1)
Further Reading
186(3)
Hyphenated Techniques
Daniel L Norwood
James O. Mullis
Thomas N. Feinberg
Abstract
189(1)
Introduction and Background
190(1)
Combined Liquid Chromatography/Mass Spectrometry
191(27)
Combined Liquid Chromatography/Nuclear Magnetic Resonance Spectroscopy
218(13)
Conclusions
231(7)
Acknowledgments
231(1)
References
232(5)
HPLC Sample Preparation
Gregory C. Slack
Nicholas H. Snow
Abstract
237(1)
Introduction
238(1)
Fundamentals of Extraction and Chemical Equilibrium
239(6)
Choice of Samples Preparation
245(1)
Direct Injection
246(1)
Liquid-Liquid Extraction
247(1)
Solid-Phase Extraction
248(6)
Solid Samples
254(2)
Additional Sample Preparation Methods
256(7)
Conclusions
263(7)
References
263(7)
Instrument Qualification and Software Validation
Dave Van Geel
Abstract
270(1)
Introduction
270(1)
Definitions
271(7)
Qualification Model
278(13)
Discussion: Case Study HPLC
291(3)
Summary and Conclusions
294(4)
Acknowledgments
295(1)
References
295(2)
Pharmaceutical Development: From Pre-Clinical to Post Approval
Kevin C. Bynum
Abstract
297(1)
Introduction
298(2)
The Role of HPLC in Drug Discovery
300(3)
The Role of HPLC in Pre-clinical Development
303(4)
The Role of HPLC in Clinical Development
307(5)
Post Approval
312(3)
Conclusions
315(3)
References
315(3)
HPLC Method Development for Drug Discovery LC-MS Assays in Rapid PK Applications
Xiaoying Xu
Abstract
318(1)
Introduction
318(1)
Tandem MS Selected Reaction Monitoring (SRM) Development
319(3)
HPLC Method Development
322(2)
Sample Preparation
324(5)
Matrix Effects
329(5)
Background Interference: Enhanced Mass Resolution Strategy
334(6)
Limit of Quantitation, Dynamic Range and Linearity
340(4)
Assay Samples and Generate Pharmacokinetic Reports
344(1)
Conclusions
345(9)
Acknowledgment
345(1)
References
345(8)
HPLC Method Development in Early Phase Pharmaceutical Development
Henrik T. Rasmussen
Kelly A. Swinney
Sheetal Gaiki
Abstract
353(1)
Introduction
354(1)
Forced Decomposition and Impurity Profiling
355(2)
Orthogonal Screening
357(5)
Method Selection and Optimization
362(4)
Additional Methods
366(1)
Setting the Stage for Late Phase HPLC Method Developments
367(2)
Conclusions
369(5)
Acknowledgments
369(1)
References
369(4)
HPLC Method Development in Late Phase Pharmaceutical Development
M. Ilias Jimidar
Maurits De Smet
Abstract
373(1)
Introduction
374(1)
Goals of Development
375(2)
Planning Phase
377(5)
Method Development Phase
382(12)
Method Evaluation Phase
394(4)
Method Transfer Phase
398(2)
Method Performance Monitoring and Feedback
400(3)
Method Development Cycle Times and Documentation
403(1)
Conclusions
403(4)
References
404(3)
Use of HPLC for In-process Testing
Christine F. Richardson
Abstract
407(1)
Introduction
407(2)
Various Examples of In-Process Testing in Drug Substance Development
409(10)
Fast HPLC
419(1)
In-Process Testing in Chemical Production
420(2)
In-Process Testing in Pharmaceutical Production
422(1)
Conclusions and Future Directions
423(3)
Acknowledgments
423(1)
References
423(2)
Method Development for Biomolecules
Julee L. Driver
Douglas E. Raynie
Abstract
425(1)
Introduction
426(4)
Protein and Peptide Separations by HPLC
430(4)
Case Studies
434(3)
Summary and Conclusions
437(5)
Abbreviations
438(1)
References
438(3)
Method Validation
M. Ilias Jimidar
Patrick Heylen
Maurits De Smet
Abstract
441(1)
Introduction
442(2)
Validation Process
444(1)
Validation Characteristics
444(6)
Additional Validation Characteristics
450(2)
Robustness Testing
452(5)
Conclusions
457(3)
References
457(2)
Troubleshooting in High Performance Liquid Chromatography
Harold Mcnair
Lee N. Polite
Abstract
459(1)
Introduction
460(1)
Problems Observed in Chromatograms
460(8)
Operating Parameters
468(4)
Leaks
472(2)
Pressure Problems
474(1)
Troubleshooting Action Plan
475(2)
Conclusions
477(2)
References
477(1)
Internet Resources
477(2)
Molecularly Imprinted Polymers as Sorbents for Separations and Extractions
Myra T. Koesdjojo
Yolanda H. Tennico
Vincent T. Remcho
Abstract
479(1)
Introduction
479(2)
MIP Theory
481(6)
Synthesis
487(4)
Use of Imprinted Polymers in Separation Science
491(2)
Pharmaceutical Application for MIPs
493(2)
Pros and Cons of MIP Sorbents
495(1)
Conclusions and Future Outlook
496
References
497
Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017).
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