Elsevier S & T

Handbook of Pharmaceutical Analysis by HPLC

Ahuja, Satinder; Dong, Michael

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Table of contents

Contentsv
Prefacexv
Contributorsxvii
Chapter 1. Overview: Handbook of Pharmaceutical Analysis by HPLC1
I. Introduction1
II. Key Concepts in HPLC3
III. HPLC Instrumentation in Pharmaceutical Analysis3
IV. HPLC Columns in Pharmaceutical Analysis4
V. Sample Preparation4
VI. Method Development5
VII. Method Validation5
VIII. Ion Chromatography6
IX. How to be More Successful with HPLC Analysis6
X. Regulatory Practices7
XI. HPLC System Calibration7
XII. System Validation8
XIII. Assay and Stability Testing9
XIV. Impurity Evaluations9
XV. Dissolution Testing10
XVI. Cleaning Validation11
XVII. High-throughput Screening11
XVIII. Chiral Separations12
XIX. LC-MS13
XX. LC-NMR14
XXI. Chromatography Data Processing16
XXII. New Developments in HPLC16
References16
Chapter 2. Key Concepts of HPLC in Pharmaceutical Analysis19
Abstract20
I. Introduction20
II. Fundamental Concepts22
Ill. Mobile Phase Parameters35
IV. Isocratic Vs. Gradient Analysis39
V. Limit of Quantitation43
VI. Glossary of HPLC Terms43
VII. Summary and Conclusion44
Acknowledgments44
References44
Chapter 3. HPLC Instrumentation in Pharmaceutical Analysis: Status, Advances, and Trends47
Abstract48
I. Introduction48
II. HPLC Solvent Delivery Systems50
III. Manual Injectors58
IV. Autosamplers59
V. Detectors62
VI. UV/VIS Absorbance Detectors62
VII. Photodiode Array (PDA) Detectors65
VIII. Other Detectors67
IX. Data Handling69
X. Instrumental Bandwidth (IBW)69
XI. Instrumentation Trends in Pharmaceutical Analysis72
XII. Manufacturers73
XIII. Summary and Conclusion73
Acknowledgments73
References73
Chapter 4. HPLC Columns for Pharmaceutical Analysis77
Abstract77
I. Introduction78
II. Column Physics78
III. Column Chemistry97
IV. Summary119
References120
Chapter 5. Sample Preparation for HPLC Analysis of Drug Products123
Abstract123
I. Introduction124
II. Sample Preparation Overview125
III. Primary SP Concerns for Types of Analysis133
IV. Sample Preparation Trends in Pharmaceutical Analysis134
V. Case Studies135
VI. Summary and Conclusion142
Acknowledgments142
References143
Chapter 6. HPLC Method Development145
Abstract145
I. Introduction146
II. Phase-Appropriate Method Development147
III. Proactive Method Development149
IV. Development, Validation, and Use of Early Phase Methods159
V. Final Method Development and Validation166
VI. Conclusions187
Acknowledgments188
References188
Chapter 7. Validation of HPLC Methods in Pharmaceutical Analysis191
Abstract192
I. Introduction192
II. Validation Requirements for Method Type194
III. Procedures and Protocols196
IV. Validation Parameters197
V. Method Validation by Phase of Development211
VI. Reference Standards212
VII. Method Transfer212
VIII. Documentation213
IX. Method Revalidation213
X. Method-Validation Software215
XI. Summary216
Acknowledgments216
References216
Chapter 8. Ion Chromatography219
Abstract219
I. Introduction219
II. Ion Chromatography Instrumentation220
III. Chromatographic Components221
IV. Pharmaceutical Ion Chromatography Applications248
V. Summary and Conclusions253
Acknowledgments253
References253
Chapter 9. How to Be More Successful with HPLC Analysis: Practical Aspects in HPLC Operation255
Abstract255
I. Introduction256
II. Mobile Phase Preparation256
III. HPLC Pump-operating Guides259
IV. HPLC Column-operating Guides259
V. Detector-operating Guides260
VI. Autosampler-operating Guides261
VII. Quantitation-operating Guides262
VIII. System Shutdown-operating Guides263
IX. Summary of HPLC Operation263
X. Keys for Success in HPLC263
XI. Enhancing HPLC Precision265
XII. Conclusion and Summary269
Acknowledgments270
References270
Chapter 10. Regulatory Considerations in HPLC Analysis273
Abstract273
I. Introduction273
II. Chromatography„Some Generalities274
III. Validation of Chromatographic Methods276
IV. Impurities286
V. Overview of Available Guidance Documents290
VI. Conclusions290
VII. Summary290
Chapter 11. HPLC System Calibration for GMP Compliance291
Abstract291
I. Introduction291
II. Overall Calibration Strategies292
Ill. Calibration Procedure: A Case Study293
IV. Overall Procedures and Documentation299
V. Summary and Conclusion300
Acknowledgments301
References301
Chapter 12. System Validation: Pre-lnstallation, IQ, OQ, and PQ303
Abstract303
I. Introduction: What is Validation, and Why Validate?304
II. Timeline and Definitions304
III. Pre-Installation305
IV. Upon Installation309
V. Post-Installation323
VI. Summary332
Acknowledgments333
References333
Chapter 13. Assay and Stability Testing335
Abstract335
I. Introduction336
II. Stability Program in Pharmaceutical Development338
III. Stability Testing by HPLC346
IV. Summary and Conclusion357
Acknowledgments357
References358
Chapter 14. Impurity Evaluations359
Abstract359
I. Introduction359
II. Drug Substance Evaluation363
III. Impurities in Dosage Forms375
IV. Summary and Conclusion377
Disclaimer377
References377
Chapter 15. HPLC in Dissolution Testing379
Abstract379
I. Introduction380
II. Utility of HPLC Analysis in Dissolution Testing383
Ill. Considerations of HPLC Methods in Dissolution Testing385
IV. HPLC in Automated and Robot-Assisted Dissolution Testing390
V. Requirements of HPLC Methods for Dissolution Testing During Drug Development Process396
VI. Conclusion398
Acknowledgments399
References399
Chapter 16. Cleaning Validation using HPLC for Analysis401
Abstract401
I. Introduction401
II. Role of the Analyst402
III. Linearity, Detection and Quantitation403
IV. Validation of Rinse and Swabbing Procedures404
V. Recovery Studies off Surfaces407
VI. Verification of the Cleaning Procedure410
VII. Verifying the Removal of Cleaning Agents410
VIII. Conclusion411
Acknowledgments412
References412
Chapter 17. LC/MS Application in High-Throughput ADME Screen413
Abstract413
I. Introduction414
II. Measurement of Physicochemical Properties415
Ill. Cytochrome P450 Inhibition Assay424
IV. Stability427
V. Metabolite Profiling430
VI. Quantitative Bioanalysis432
VII. Summary and Conclusion438
Acknowledgments439
References439
Chapter 18. Chiral Separations447
Abstract447
I. Introduction448
II. Separation of Enantiomers of Pharmaceutical Interest Using LC and CE453
III. Separation of Enantiomers by Capillary Electrophoresis457
IV. Separation of Enantiomers by Liquid Chromatography on Chiral Stationary Phases463
V. Practical Guidelines to Chiral HPLC Separations of Pharmaceuticals483
VI. Conclusion488
References489
Chapter 19. Applications of LC/MS in Pharmaceutical Analysis499
Abstract500
I. Introduction500
II. LC/MS Interfaces503
III. Mass Analyzers514
IV. Practical Considerations in Selection of LC/MS Parameters518
V. Peak Tracking Between LC/UV and LC/MS Methods526
VI. Development of Generic LC/MS Method and LC/MS Database528
VII. MS-Assisted HPLC Method Development and Validation535
VIII. Impurity Profiling for Drug Substances and Pharmaceutical Products541
IX. Supporting Marketed Drug Products553
X. Conclusion564
Acknowledgments565
References565
Chapter 20. Application of LC-NMR in Pharmaceutical Analysis569
Abstract569
I. Introduction570
II. Instrumentation and Design571
III. Practical Applications573
IV. Related Hyphenated Techniques576
V. Conclusion578
References578
Chapter 21. Chromatography Data Systems (CDS) in the Pharmaceutical Laboratory: Its History, Advance581
Abstract581
I. Introduction582
II. A Historical Look at CDS Development582
III. Technological Advances588
IV. Specific Needs of the Pharmaceutical Industry602
V. Future Direction608
Acknowledgments609
References609
Chapter 22. New Developments in HPLC611
Abstract611
I. Introduction611
II. Simplifying Sample Preparation612
III. New Column Technologies614
IV. Improvements in Detectors615
V. Improvements in HPLC Throughput616
VI. Summary627
Acknowledgments628
References628
Index631

Book details

Vendor Elsevier S & T
SKU 9780120885473
ISBN-13 9780080455181
Author Ahuja, Satinder; Dong, Michael
Category Medical
Subject Pharmacology

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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

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