HPLC Method Development for Pharmaceuticals Volume 8 Separation Science and Technology 1st Edition by Satinder Ahuja, Henrik Rasmussen ISBN 0080554199 9780080554198

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Product details:

ISBN 10: 0080554199

ISBN 13: 9780080554198

Author:  Satinder Ahuja, Henrik Rasmussen 

HPLC Method Development for Pharmaceuticals (Volume 8: Separation Science and Technology) 1st Edition: 

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

 

HPLC Method Development for Pharmaceuticals (Volume 8: Separation Science and Technology) 1st Edition Table of contents:

Chapter 1: Overview of HPLC Method Development for Pharmaceuticals

• I. Introduction
• II. Theoretical Considerations
• III. HPLC Columns and Column Packings
• IV. Column Selection
• V. Chiral Separations
• VI. Contemporary HPLC
• VII. Hyphenated Methods
• VIII. Sample Preparation
• IX. Instrument Qualification and Software Validation
• X. Pharmaceutical Development
• XI. Drug Discovery
• XII. Early Phase Method Development
• XIII. Late Phase Development
• XIV. In-Process Testing
• XV. Method Development for Biomolecules
• XVI. Method Validation
• XVII. Troubleshooting
• XVIII. Molecularly Imprinted Polymers
• References

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Chapter 2: HPLC Theory

• Abstract
• I. Introduction
• II. Basic Chromatographic Descriptors
• III. Efficiency
• IV. Resolution
• V. Main Components of the Retention Mechanism
• VI. General Column Mass Balance
• VII. Partitioning Model
• VIII. Adsorption Model
• IX. Void Volume Considerations
• X. Thermodynamic Relationships
• XI. Secondary Equilibria
• XII. Salt Effect
• XIII. Effect of Different Counteranions
• XIV. Inclusion of Secondary Equilibria in the Mass Balance
• XV. Conclusions
• References

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Chapter 3: HPLC Columns and Packings

• Abstract
• I. Introduction
• II. Column Chemistry
• III. Speed and Resolution
• IV. Specialty Columns from Nanobore to Preparative Chromatography
• V. Summary
• References

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Chapter 4: Column Characterization and Selection

• Abstract
• I. Introduction
• II. Characteristics of RP-HPLC Columns and Chromatographic Tests
• III. Column Classification and Selection
• IV. Conclusions
• Acknowledgment
• References

---

Chapter 5: Chiral Separations

• Abstract
• I. Introduction
• II. Separation of Enantiomers on HPLC Chiral Stationary Phases
• III. Practical Guidelines to Chiral HPLC of Pharmaceuticals
• IV. Conclusions
• References

---

Chapter 6: Contemporary Liquid Chromatographic Systems for Method Development

• Abstract
• I. Introduction
• II. Traditional Instrumentation for HPLC Method Development
• III. Contemporary Method Development Systems
• IV. Migrating Methods from HPLC to UPLC
• V. UPLC Applications in Pharmaceutical Analysis
• VI. Summary and Conclusions
• Acknowledgments
• References
• Further Reading

---

Chapter 7: Hyphenated Techniques

• Abstract
• I. Introduction and Background
• II. Combined Liquid Chromatography/Mass Spectrometry
• III. Combined Liquid Chromatography/Nuclear Magnetic Resonance Spectroscopy
• IV. Conclusions
• Acknowledgments
• References

---

Chapter 8: HPLC Sample Preparation

• Abstract
• I. Introduction
• II. Fundamentals of Extraction and Chemical Equilibrium
• III. Choice of Samples Preparation
• IV. Direct Injection
• V. Liquid–Liquid Extraction
• VI. Solid-Phase Extraction
• VII. Solid Samples
• VIII. Additional Sample Preparation Methods
• IX. Conclusions
• References

---

Chapter 9: Instrument Qualification and Software Validation

• Abstract
• I. Introduction
• II. Definitions
• III. Qualification Model
• IV. Discussion: Case Study HPLC
• V. Summary and Conclusions
• Acknowledgments
• References

---

Chapter 10: Pharmaceutical Development: From Pre-Clinical to Post Approval

• Abstract
• I. Introduction
• II. The Role of HPLC in Drug Discovery
• III. The Role of HPLC in Pre-clinical Development
• IV. The Role of HPLC in Clinical Development
• V. Post Approval
• VI. Conclusions
• References

---

Chapter 11: HPLC Method Development for Drug Discovery LC-MS Assays in Rapid PK Applications

• Abstract
• I. Introduction
• II. Tandem MS Selected Reaction Monitoring (SRM) Development
• III. HPLC Method Development
• IV. Sample Preparation
• V. Matrix Effects
• VI. Background Interference: Enhanced Mass Resolution Strategy
• VII. Limit of Quantitation, Dynamic Range, and Linearity
• VIII. Assay Samples and Generate Pharmacokinetic Reports
• IX. Conclusions
• Acknowledgment
• References

---

Chapter 12: HPLC Method Development in Early Phase Pharmaceutical Development

• Abstract
• I. Introduction
• II. Forced Decomposition and Impurity Profiling
• III. Orthogonal Screening
• IV. Method Selection and Optimization
• V. Additional Methods
• VI. Setting the Stage for Late Phase HPLC Method Developments
• VII. Conclusions
• Acknowledgments
• References

---

Chapter 13: HPLC Method Development in Late Phase Pharmaceutical Development

• Abstract
• I. Introduction
• II. Goals of Development
• III. Planning Phase
• IV. Method Development Phase
• V. Method Evaluation Phase
• VI. Method Transfer Phase
• VII. Method Performance Monitoring and Feedback
• VIII. Method Development Cycle Times and Documentation
• IX. Conclusions
• References

---

Chapter 14: Use of HPLC for In-process Testing

• Abstract
• I. Introduction
• II. Various Examples of In-Process Testing in Drug Substance Development
• III. Fast HPLC
• IV. In-Process Testing in Chemical Production
• V. In-Process Testing in Pharmaceutical Production
• VI. Conclusions and Future Directions
• Acknowledgments
• References

---

Chapter 15: Method Development for Biomolecules

• Abstract
• I. Introduction
• II. Protein and Peptide Separations by HPLC
• III. Case Studies
• IV. Summary and Conclusions
• Abbreviations
• References

---

Chapter 16: Method Validation

• Abstract
• I. Introduction
• II. Validation Process
• III. Validation Characteristics
• IV. Additional Validation Characteristics
• V. Robustness Testing
• VI. Conclusions
• References

---

Chapter 17: Troubleshooting in High-Performance Liquid Chromatography

• Abstract
• I. Introduction
• II. Problems Observed in Chromatograms
• III. Operating Parameters
• IV. Leaks
• V. Pressure Problems
• VI. Troubleshooting Action Plan
• VII. Conclusions
• References
• Internet Resources

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Chapter 18: Molecularly Imprinted Polymers as Sorbents for Separations and Extractions

• Abstract
• I. Introduction
• II. MIP Theory
• III. Synthesis
• IV. Use of Imprinted Polymers in Separation Science
• V. Pharmaceutical Application for MIPs
• VI. Pros and Cons of MIP Sorbents
• VII. Conclusions and Future Outlook

 

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