Handbook of Pharmaceutical Analysis by HPLC [1 ed.] 0120885476, 9780120885473, 9780080455181

Table of contents :
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