High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening, * A complete reference guide to HPLC* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Author(s): Satinder Ahuja and Michael W. Dong (Eds.)
Series: Separation Science and Technology 6
Edition: 1
Publisher: Academic Press
Year: 2005
Language: English
Pages: 1-658
Content:
Preface
Pages xv-xvi
Satinder (Sut) Ahuja, Michael Dong
Contributors
Pages xvii-xix
1 Overview: Handbook of pharmaceutical analysis by HPLC Original Research Article
Pages 1-17
Satinder Ahuja
2 Key concepts of HPLC in pharmaceutical analysis Original Research Article
Pages 19-45
Raphael M. Ornaf, Michael W. Dong
3 HPLC instrumentation in pharmaceutical analysis: Status, advances, and trends Original Research Article
Pages 47-75
Michael W. Dong
4 HPLC columns for pharmaceutical analysis Original Research Article
Pages 77-122
Uwe D. Neue, Bonnie A. Alden, Pamela C. Iraneta, Alberto Méndez, Eric S. Grumbach, Kimvan Tran, Diane M. Diehl
5 Sample preparation for HPLC analysis of drug products Original Research Article
Pages 123-144
Clark K. Choi, Michael W. Dong
6 HPLC method development Original Research Article
Pages 145-190
Henrik T. Rasmussen, Weiyong Li, Dirk Redlich, M. Ilias Jimidar
7 Validation of HPLC methods in pharmaceutical analysis Original Research Article
Pages 191-217
Ashley S. Lister
8 Ion chromatography Original Research Article
Pages 219-254
Christopher Pohl
9 How to be more successful with HPLC analysis: Practical aspects in HPLC operation Original Research Article
Pages 255-271
Michael W. Dong
10 Regulatory considerations in HPLC analysis Original Research Article
Pages 273-290
Christine F. Richardson, Fritz Erni
11 HPLC system calibration for GMP compliance Original Research Article
Pages 291-301
Michael W. Dong
12 System validation: Pre-installation, IQ, OQ, and PQ Original Research Article
Pages 303-333
Wilhad M. Reuter
13 Assay and stability testing Original Research Article
Pages 335-358
Anissa W. Wong, Aruna Datla
14 Impurity evaluations Original Research Article
Pages 359-377
Todd Cecil, Eric Sheinin
15 HPLC in dissolution testing Original Research Article
Pages 379-400
Qingxi Wang, Vivian Gray
16 Cleaning validation using HPLC for analysis Original Research Article
Pages 401-412
Andrew Plasz
17 LC/MS application in high-throughput adme screen Original Research Article
Pages 413-446
Ron Kong
18 Chiral separations Original Research Article
Pages 447-498
Y. Vander Heyden, D. Mangelings, N. Matthijs, C. Perrin
19 Applications of LC/MS in pharmaceutical analysis Original Research Article
Pages 499-568
Leon Z. Zhou
20 Application of LC-NMR in pharmaceutical analysis Original Research Article
Pages 569-579
Mieng-Hua Wann
21 Chromatography data systems (CDS) in the pharmaceutical laboratory: Its history, advances, and future direction Original Research Article
Pages 581-609
Robert P. Mazzarese
22 New developments in HPLC Original Research Article
Pages 611-629
Satinder Ahuja, Diane M. Diehl
Index
Pages 631-658
