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E-grāmata: Handbook of Pharmaceutical Analysis by HPLC

Edited by (President, Ahuja Consulting for Water Quality, Calabash, NC, USA), Edited by (Purdue Pharma, Ardsley, NY, USA)
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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

Papildus informācija

A comprehensive guide to HPLC theory, hardware, methodologies, regulations, applications and new developments
Preface xv
Contributors xvii
Overview: Handbook of Pharmaceutical Analysis by HPLC
Satinder Ahuja
Introduction
1(2)
Key Concepts in HPLC
3(1)
HPLC Instrumentation in Pharmaceutical Analysis
3(1)
HPLC Columns in Pharmaceutical Analysis
4(1)
Sample Preparation
4(1)
Method Development
5(1)
Method Validation
5(1)
Ion Chromatography
6(1)
How to be More Successful with HPLC Analysis
6(1)
Regulatory Practices
7(1)
HPLC System Calibration
7(1)
System Validation
8(1)
Assay and Stability Testing
9(1)
Impurity Evaluations
9(1)
Dissolution Testing
10(1)
Cleaning Validation
11(1)
High-throughput Screening
11(1)
Chiral Separations
12(1)
LC-MS
13(1)
LC-NMR
14(2)
Chromatography Data Processing
16(1)
New Developments in HPLC
16(4)
References
16(4)
Key Concepts of HPLC in Pharmaceutical Analysis
Raphael M. Ornaf
Michael W. Dong
Abstract
20(1)
Introduction
20(2)
Fundamental Concepts
22(13)
Mobile Phase Parameters
35(4)
Isocratic Vs. Gradient Analysis
39(4)
Limit of Quantitation
43(1)
Glossary of HPLC Terms
43(1)
Summary and Conclusion
44(4)
Acknowledgments
44(1)
References
44(4)
HPLC Instrumentation in Pharmaceutical Analysis: Status, Advances, and Trends
Michael W. Dong
Abstract
48(1)
Introduction
48(2)
HPLC Solvent Delivery Systems
50(8)
Manual Injectors
58(1)
Autosamplers
59(3)
Detectors
62(1)
UV/Vis Absorbance Detectors
62(3)
Photodiode Array (PDA) Detectors
65(2)
Other Detectors
67(2)
Data Handling
69(1)
Instrumental Bandwidth (IBW)
69(3)
Instrumentation Trends in Pharmaceutical Analysis
72(1)
Manufacturers
73(1)
Summary and Conclusion
73(5)
Acknowledgments
73(1)
References
73(4)
HPLC Columns for Pharmaceutical Analysis
Uwe D. Neue
Bonnie A. Alden
Pamela C. Iraneta
Alberto Mendez
Eric S. Grumbach
Kimvan Tran
Diane M. Diehl
Abstract
77(1)
Introduction
78(1)
Column Physics
78(19)
Column Chemistry
97(22)
Summary
119(1)
References
120(3)
Sample Preparation for HPLC Analysis of Drug Products
Clark K. Choi
Michael W. Dong
Abstract
123(1)
Introduction
124(1)
Sample Preparation Overview
125(8)
Primary SP Concerns for Types of Analysis
133(1)
Sample Preparation Trends in Pharmaceutical Analysis
134(1)
Case Studies
135(7)
Summary and Conclusion
142(4)
Acknowledgments
142(1)
References
143(2)
HPLC Method Development
Henrik T. Rasmussen
Weiyong Li
Dirk Redlich
M. Ilias Jimidar
Abstract
145(1)
Introduction
146(1)
Phase-Appropriate Method Development
147(2)
Proactive Method Development
149(10)
Development, Validation, and Use of Early Phase Methods
159(7)
Final Method Development and Validation
166(21)
Conclusions
187(5)
Acknowledgments
188(1)
References
188(4)
Validation of HPLC Methods in Pharmaceutical Analysis
Ashley S. Lister
Abstract
192(1)
Introduction
192(2)
Validation Requirements for Method Type
194(2)
Procedures and Protocols
196(1)
Validation Parameters
197(14)
Method Validation by Phase of Development
211(1)
Reference Standards
212(1)
Method Transfer
212(1)
Documentation
213(1)
Method Revalidation
213(2)
Method-Validation Software
215(1)
Summary
216(3)
Acknowledgments
216(1)
References
216(3)
Ion Chromatography
Christopher Pohl
Abstract
219(1)
Introduction
219(1)
Ion Chromatography Instrumentation
220(1)
Chromatographic Components
221(27)
Pharmaceutical Ion Chromatography Applications
248(5)
Summary and Conclusions
253(3)
Acknowledgments
253(1)
References
253(2)
How to Be More Successful with HPLC Analysis: Practical Aspects in HPLC Operation
Michael W. Dong
Abstract
255(1)
Introduction
256(1)
Mobile Phase Preparation
256(3)
HPLC Pump-operating Guides
259(1)
HPLC Column-operating Guides
259(1)
Detector-operating Guides
260(1)
Autosampler-operating Guides
261(1)
Quantitation-operating Guides
262(1)
System Shutdown-operating Guides
263(1)
Summary of HPLC Operation
263(1)
Keys for Success in HPLC
263(2)
Enhancing HPLC Precision
265(4)
Conclusion and Summary
269(4)
Acknowledgments
270(1)
References
270(3)
Regulatory Considerations in HPLC Analysis
Christine F. Richardson
Fritz Erni
Abstract
273(1)
Introduction
273(1)
Chromatography---Some Generalities
274(2)
Validation of Chromatographic Methods
276(10)
Impurities
286(4)
Overview of Available Guidance Documents
290(1)
Conclusions
290(1)
Summary
290(1)
HPLC System Calibration for GMP Compliance
Michael W. Dong
Abstract
291(1)
Introduction
291(1)
Overall Calibration Strategies
292(1)
Calibration Procedure: A Case Study
293(6)
Overall Procedures and Documentation
299(1)
Summary and Conclusion
300(4)
Acknowledgments
301(1)
References
301(2)
System Validation: Pre-Installation, IQ, OQ, and PQ
Wilhad M. Reuter
Abstract
303(1)
Introduction: What is Validation, and Why Validate?
304(1)
Timeline and Definitions
304(1)
Pre-Installation
305(4)
Upon Installation
309(14)
Post-Installation
323(9)
Summary
332(4)
Acknowledgments
333(1)
References
333(2)
Assay and Stability Testing
Anissa W. Wong
Aruna Datla
Abstract
335(1)
Introduction
336(2)
Stability Program in Pharmaceutical Development
338(8)
Stability Testing by HPLC
346(11)
Summary and Conclusion
357(2)
Acknowledgments
357(1)
References
358(1)
Impurity Evaluations
Todd Cecil
Eric Sheinin
Abstract
359(1)
Introduction
359(4)
Drug Substance Evaluation
363(12)
Impurities in Dosage Forms
375(2)
Summary and Conclusion
377(3)
Disclaimer
377(1)
References
377(2)
HPLC in Dissolution Testing
Qingxi Wang
Vivian Gray
Abstract
379(1)
Introduction
380(3)
Utility of HPLC Analysis in Dissolution Testing
383(2)
Considerations of HPLC Methods in Dissolution Testing
385(5)
HPLC in Automated and Robot-Assisted Dissolution Testing
390(6)
Requirements of HPLC Methods for Dissolution Testing During Drug Development Process
396(2)
Conclusion
398(3)
Acknowledgments
399(1)
References
399(2)
Cleaning Validation using HPLC for Analysis
Andrew Plasz
Abstract
401(1)
Introduction
401(1)
Role of the Analyst
402(1)
Linearity, Detection and Quantitation
403(1)
Validation of Rinse and Swabbing Procedures
404(3)
Recovery Studies off Surfaces
407(3)
Verification of the Cleaning Procedure
410(1)
Verifying the Removal of Cleaning Agents
410(1)
Conclusion
411(3)
Acknowledgments
412(1)
References
412(1)
LC/MS Application in High-Throughput ADME Screen
Ron Kong
Abstract
413(1)
Introduction
414(1)
Measurement of Physicochemical Properties
415(9)
Cytochrome P450 Inhibition Assay
424(3)
Stability
427(3)
Metabolite Profiling
430(2)
Quantitative Bioanalysis
432(6)
Summary and Conclusion
438(10)
Acknowledgments
439(1)
References
439(8)
Chiral Separations
Y. Vander Heyden
D. Mangelings
N. Matthijs
C. Perrin
Abstract
447(1)
Introduction
448(5)
Separation of Enantiomers of Pharmaceutical Interest Using LC and CE
453(4)
Separation of Enantiomers by Capillary Electrophoresis
457(6)
Separation of Enantiomers by Liquid Chromatography on Chiral Stationary Phases
463(20)
Practical Guidelines to Chiral HPLC Separations of Pharmaceuticals
483(5)
Conclusion
488(12)
References
489(11)
Applications of LC/MS in Pharmaceutical Analysis
Leon Z. Zhou
Abstract
500(1)
Introduction
500(3)
LC/MS Interfaces
503(11)
Mass Analyzers
514(4)
Practical Considerations in Selection of LC/MS Parameters
518(8)
Peak Tracking Between LC/UV and LC/MS Methods
526(2)
Development of Generic LC/MS Method and LC/MS Database
528(7)
MS-Assisted HPLC Method Development and Validation
535(6)
Impurity Profiling for Drug Substances and Pharmaceutical Products
541(12)
Supporting Marketed Drug Products
553(11)
Conclusion
564(6)
Acknowledgments
565(1)
References
565(4)
Application of LC-NMR in Pharmaceutical Analysis
Mieng-Hua Wann
Abstract
569(1)
Introduction
570(1)
Instrumentation and Design
571(2)
Practical Applications
573(3)
Related Hyphenated Techniques
576(2)
Conclusion
578(4)
References
578(3)
Chromatography Data Systems (CDS) in the Pharmaceutical Laboratory: Its History, Advances, and Future Direction
Robert P. Mazzarese
Abstract
581(1)
Introduction
582(1)
A Historical Look at CDS Development
582(6)
Technological Advances
588(14)
Specific Needs of the Pharmaceutical Industry
602(6)
Future Direction
608(3)
Acknowledgments
609(1)
References
609(2)
New Developments in HPLC
Satinder Ahuja
Diane M. Diehl
Abstract
611(1)
Introduction
611(1)
Simplifying Sample Preparation
612(2)
New Column Technologies
614(1)
Improvements in Detectors
615(1)
Improvements in HPLC Throughput
616(11)
Summary
627(4)
Acknowledgments
628(1)
References
628(3)
Index 631


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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