HPLC Method Development for Pharmaceuticals, Volume 8

Volume 8

By: Henrik Rasmussen, Satinder Ahuja

Write A Review

Hardcover | 7 June 2007 | Edition Number 8

At a Glance

Hardcover
532 Pages

Dimensions(cm)
24.77 x 17.78 x 3.18

Hardcover

RRP $529.95

$469.90

11%OFF

or 4 interest-free payments of $117.47 with

Aims to ship in 5 to 10 business days

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

Industry Reviews

"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)

Shipping

	Standard Shipping	Express Shipping
Metro postcodes:	$9.99	$14.95
Regional postcodes:	$9.99	$14.95
Rural postcodes:	$9.99	$14.95

How to return your order

At Booktopia, we offer hassle-free returns in accordance with our returns policy. If you wish to return an item, please get in touch with Booktopia Customer Care.

Additional postage charges may be applicable.

Defective items

If there is a problem with any of the items received for your order then the Booktopia Customer Care team is ready to assist you.

For more info please visit our Help Centre.

You Can Find This Book In

Non-Fiction Medicine Other Branches of Medicine Pharmacology Science Chemistry Analytical Chemistry Chromatography Industry & Industrial Studies Manufacturing Industries Pharmaceutical Industries Nursing & Ancillary Services

Pharmacy & Dispensing

Preface	p. xiii
Contributors	p. xv
Overview of HPLC Method Development for Pharmaceuticals
Introduction	p. 1
Theoretical Considerations	p. 2
HPLC Columns and Column Packings	p. 2
Column Selection	p. 3
Chiral Separations	p. 3
Contemporary HPLC	p. 4
Hyphenated Methods	p. 5
Sample Preparation	p. 5
Instrument Qualification and Software Validation	p. 6
Pharmaceutical Development	p. 6
Drug Discovery	p. 7
Early Phase Method Development	p. 8
Late Phase Development	p. 8
In-Process Testing	p. 9
Method Development for Biomolecules	p. 9
Method Validation	p. 10
Troubleshooting	p. 10
Molecularly Imprinted Polymers	p. 10
References	p. 11
HPLC Theory
Abstract	p. 13
Introduction	p. 13
Basic Chromatographic Descriptors	p. 14
Efficiency	p. 15
Resolution	p. 20
Main Components of the Retention Mechanism	p. 22
General Column Mass Balance	p. 24
Partitioning Model	p. 27
Adsorption Model	p. 28
Void Volume Considerations	p. 29
Thermodynamic Relationships	p. 31
Secondary Equilibria	p. 35
Salt Effect	p. 37
Effect of Different Counteranions	p. 38
Inclusion of Secondary Equilibria in the Mass Balance	p. 40
Conclusions	p. 43
References	p. 43
HPLC Columns and Packings
Abstract	p. 45
Introduction	p. 46
Column Chemistry	p. 47
Speed and Resolution	p. 68
Specialty Columns from Nanobore to Preparative Chromatography	p. 77
Summary	p. 80
References	p. 80
Column Characterization and Selection
Abstract	p. 85
Introduction	p. 86
Characteristics of RP-HPLC Columns and Chromatographic Tests	p. 90
Column Classification and Selection	p. 101
Conclusions	p. 104
Acknowledgment	p. 105
References	p. 105
Chiral Separations
Abstract	p. 111
Introduction	p. 112
Separation of Enantiomers on HPLC Chiral Stationary Phases	p. 115
Practical Guidelines to Chiral HPLC of Pharmaceuticals	p. 135
Conclusions	p. 137
References	p. 138
Contemporary Liquid Chromatographic Systems for Method Development
Abstract	p. 145
Introduction	p. 146
Traditional Instrumentation for HPLC Method Development	p. 147
Contemporary Method Development Systems	p. 153
Migrating Methods from HPLC to UPLC	p. 169
UPLC Applications in Pharmaceutical Analysis	p. 174
Summary and Conclusions	p. 183
Acknowledgments	p. 184
References	p. 185
Further Reading	p. 186
Hyphenated Techniques
Abstract	p. 189
Introduction and Background	p. 190
Combined Liquid Chromatography/Mass Spectrometry	p. 191
Combined Liquid Chromatography/Nuclear Magnetic Resonance Spectroscopy	p. 218
Conclusions	p. 231
Acknowledgments	p. 231
References	p. 232
HPLC Sample Preparation
Abstract	p. 237
Introduction	p. 238
Fundamentals of Extraction and Chemical Equilibrium	p. 239
Choice of Samples Preparation	p. 245
Direct Injection	p. 246
Liquid-Liquid Extraction	p. 247
Solid-Phase Extraction	p. 248
Solid Samples	p. 254
Additional Sample Preparation Methods	p. 256
Conclusions	p. 263
References	p. 263
Instrument Qualification and Software Validation
Abstract	p. 270
Introduction	p. 270
Definitions	p. 271
Qualification Model	p. 278
Discussion: Case Study HPLC	p. 291
Summary and Conclusions	p. 294
Acknowledgments	p. 295
References	p. 295
Pharmaceutical Development: From Pre-Clinical to Post Approval
Abstract	p. 297
Introduction	p. 298
The Role of HPLC in Drug Discovery	p. 300
The Role of HPLC in Pre-clinical Development	p. 303
The Role of HPLC in Clinical Development	p. 307
Post Approval	p. 312
Conclusions	p. 315
References	p. 315
HPLC Method Development for Drug Discovery LC-MS Assays in Rapid PK Applications
Abstract	p. 318
Introduction	p. 318
Tandem MS Selected Reaction Monitoring (SRM) Development	p. 319
HPLC Method Development	p. 322
Sample Preparation	p. 324
Matrix Effects	p. 329
Background Interference: Enhanced Mass Resolution Strategy	p. 334
Limit of Quantitation, Dynamic Range and Linearity	p. 340
Assay Samples and Generate Pharmacokinetic Reports	p. 344
Conclusions	p. 345
Acknowledgment	p. 345
References	p. 345
HPLC Method Development in Early Phase Pharmaceutical Development
Abstract	p. 353
Introduction	p. 354
Forced Decomposition and Impurity Profiling	p. 355
Orthogonal Screening	p. 357
Method Selection and Optimization	p. 362
Additional Methods	p. 366
Setting the Stage for Late Phase HPLC Method Developments	p. 367
Conclusions	p. 369
Acknowledgments	p. 369
References	p. 369
HPLC Method Development in Late Phase Pharmaceutical Development
Abstract	p. 373
Introduction	p. 374
Goals of Development	p. 375
Planning Phase	p. 377
Method Development Phase	p. 382
Method Evaluation Phase	p. 394
Method Transfer Phase	p. 398
Method Performance Monitoring and Feedback	p. 400
Method Development Cycle Times and Documentation	p. 403
Conclusions	p. 403
References	p. 404
Use of HPLC for In-process Testing
Abstract	p. 407
Introduction	p. 407
Various Examples of In-Process Testing in Drug Substance Development	p. 409
Fast HPLC	p. 419
In-Process Testing in Chemical Production	p. 420
In-Process Testing in Pharmaceutical Production	p. 422
Conclusions and Future Directions	p. 423
Acknowledgments	p. 423
References	p. 423
Method Development for Biomolecules
Abstract	p. 425
Introduction	p. 426
Protein and Peptide Separations by HPLC	p. 430
Case Studies	p. 434
Summary and Conclusions	p. 437
Abbreviations	p. 438
References	p. 438
Method Validation
Abstract	p. 441
Introduction	p. 442
Validation Process	p. 444
Validation Characteristics	p. 444
Additional Validation Characteristics	p. 450
Robustness Testing	p. 452
Conclusions	p. 457
References	p. 457
Troubleshooting in High Performance Liquid Chromatography
Abstract	p. 459
Introduction	p. 460
Problems Observed in Chromatograms	p. 460
Operating Parameters	p. 468
Leaks	p. 472
Pressure Problems	p. 474
Troubleshooting Action Plan	p. 475
Conclusions	p. 477
References	p. 477
Internet Resources	p. 477
Molecularly Imprinted Polymers as Sorbents for Separations and Extractions
Abstract	p. 479
Introduction	p. 479
MIP Theory	p. 481
Synthesis	p. 487
Use of Imprinted Polymers in Separation Science	p. 491
Pharmaceutical Application for MIPs	p. 493
Pros and Cons of MIP Sorbents	p. 495
Conclusions and Future Outlook	p. 496
References	p. 497
Table of Contents provided by Ingram. All Rights Reserved.

HPLC Method Development for Pharmaceuticals, Volume 8

Volume 8

At a Glance

Hardcover

Industry Reviews

Shipping

How to return your order

Defective items

You Can Find This Book In

More in Pharmacology

Toxicology Handbook

4th edition

Havard's Nursing Guide to Drugs

11th Edition

2025 Lippincott Pocket Drug Guide for Nurses

Rang & Dale's Pharmacology

10th Edition

Targeted Therapy for Central Nervous System

Formulation, Clinical Challenges and Regulatory Strategies

Green Analytical Methods and Miniaturized Sample Preparation techniques for Forensic Drug Analysis

Encyclopedia of Remedy Relationships in Homoeopathy

Australia and New Zealand McKenna's Drug Handbook for Nursing and Midwifery

Australia and New Zealand 9th edition

Pharmacology for Anaesthesia and Intensive Care

5th Edition

The Psilocybin Mushroom Bible

The Definitive Guide to Growing and Using Magic Mushrooms

Medical Pharmacology at a Glance

9th Edition

Healing Psychedelics

Innovative Therapies for Trauma and Transformation

Cosmeceuticals

3rd Edition - Procedures in Cosmetic Dermatology Series

Australian Drug Guide (9th Ed)

The Plain Language Guide to Drugs and Medicines of All Kinds

Paramedic & Emergency Pharmacology Guidelines

2nd Edition

Drugs in Anaesthesia and Intensive Care

5th Edition

Pharmacology Made Incredibly Easy

5th edition

Kinesiology

The Mechanics and Pathomechanics of Human Movement 3rd Edition

Community Pharmacy

5th Edition - Symptoms, Diagnosis and Treatment

Pharmacokinetics Made Easy : 2nd Edition

Pocket Guide

The Therapist's Guide to Psychopharmacology, Third Edition

Working with Patients, Families, and Physicians to Optimize Care

Handbook Of Clinical Psychopharmacology For Therapists

Pharmacology for Midwives

2nd Edition - The Evidence Base for Safe Practice

Essential Herbs and Natural Supplements

This product is categorised by