Development of Novel Stability Indicating Methods Using Liquid Chromatography

Development of Novel Stability Indicating Methods Using Liquid Chromatography

Author: Mukesh Maithani

Publisher: Springer

Published: 2019-08-07

Total Pages: 117

ISBN-13: 9811387230

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Reversed-phase high-performance liquid chromatography (RP-HPLC) has become the most widely used method for pharmaceutical analysis, as it ensures accuracy, specificity and reproducibility for the quantification of drugs, while avoiding interference from any of the excipients that are normally present in pharmaceutical dosage forms. This book presents a simple methodology for developing stability-indicating methods and offers a ‘how-to guide’ to creating novel stability-indicating methods using liquid chromatography. It provides the detailed information needed to devise a stability-indicating method for drug substances and drug products that comply with international regulatory guidelines. As such, it is a must-read for anyone engaged in analytical and bioanalytical chemistry: professionals at reference, test, and control laboratories; students and academics at research laboratories, and scientists working for chemical, pharmaceutical, and biotechnology companies.


Separation Methods in Drug Synthesis and Purification

Separation Methods in Drug Synthesis and Purification

Author: Klara Valko

Publisher: Elsevier

Published: 2020-06-19

Total Pages: 790

ISBN-13: 0444640711

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Separation Methods in Drug Synthesis and Purification, Second Edition, Volume Eight, provides an updated on the analytical techniques used in drug synthesis and purification. Unlike other books on either separation science or drug synthesis, this volume combines the two to explain the basic principles and comparisons of each separation technique. New sections to this volume include enantiomer separation using capillary electrophoresis (CE) and capillary electro- chromatography, the computer simulation of chromatographic separation for accelerating method development, the application of chromatography and capillary electrophoresis used as surrogates for biological processes, and new developments in the established techniques of chromatography and preparative methods. - Features descriptions and applications of all separation methods used in the pharmaceutical industry - Written by the leading scientists in their respective fields, providing solutions for a wide range of industrial separation problems encountered within the pharmaceutical industry - Thoroughly updated with brand new separation science techniques and the latest developments in the established techniques of chromatography


Practical HPLC Method Development

Practical HPLC Method Development

Author: Lloyd R. Snyder

Publisher: Wiley-Interscience

Published: 1988

Total Pages: 296

ISBN-13:

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Designed for the professional chemist who is already familiar with the basics of high performance liquid chromatography, this book explains how to develop separation methods for a variety of situations. It focuses on reversed-phase separations of small molecules and development of separations.


Analytical Method Development and Validation

Analytical Method Development and Validation

Author: Michael E. Swartz

Publisher: CRC Press

Published: 2017-09-28

Total Pages:

ISBN-13: 9781138402560

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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.


High-Performance Gradient Elution

High-Performance Gradient Elution

Author: Lloyd R. Snyder

Publisher: John Wiley & Sons

Published: 2007-01-09

Total Pages: 496

ISBN-13: 0470055510

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Gradient elution demystified Of the various ways in which chromatography is applied today, few have been as misunderstood as the technique of gradient elution, which presents many challenges compared to isocratic separation. When properly explained, however, gradient elution can be less difficult to understand and much easier to use than often assumed. Written by two well-known authorities in liquid chromatography, High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model takes the mystery out of the practice of gradient elution and helps remove barriers to the practical application of this important separation technique. The book presents a systematic approach to the current understanding of gradient elution, describing theory, methodology, and applications across many of the fields that use liquid chromatography as a primary analytical tool. This up-to-date, practical, and comprehensive treatment of gradient elution: * Provides specific, step-by-step recommendations for developing a gradient separation for any sample * Describes the best approach for troubleshooting problems with gradient methods * Guides the reader on the equipment used for gradient elution * Lists which conditions should be varied first during method development, and explains how to interpret scouting gradients * Explains how to avoid problems in transferring gradient methods With a focus on the use of linear solvent strength (LSS) theory for predicting gradient LC behavior and separations by reversed-phase HPLC, High-Performance Gradient Elution gives every chromatographer access to this useful tool.


Preparative Chromatography for Separation of Proteins

Preparative Chromatography for Separation of Proteins

Author: Arne Staby

Publisher: John Wiley & Sons

Published: 2017-03-06

Total Pages: 577

ISBN-13: 1119031109

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Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers


Scale-Up and Optimization in Preparative Chromatography

Scale-Up and Optimization in Preparative Chromatography

Author: Anurag Rathore

Publisher: CRC Press

Published: 2002-09-26

Total Pages: 368

ISBN-13: 9780203909287

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Presenting guidelines to predict and improve separation system performance, this book contains numerous case studies illustrating the practice of scale-up principles in process development. It offers solutions to limitations that occur in real-world purification schemes; methods to model, optimize, and characterize nonlinear separation processes; d


Multidimensional Liquid Chromatography

Multidimensional Liquid Chromatography

Author: Steven A. Cohen

Publisher: John Wiley & Sons

Published: 2008-05-09

Total Pages: 490

ISBN-13: 0470276258

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Multidimensional Liquid Chromatography (MDLC) is a very powerful separation technique for analyzing exceptionally complex samples in one step. This authoritative reference presents a number of recent contributions that help define the current art and science of MDLC. Topics covered include instrumentation, theory, methods development, and applications of MDLC in the life sciences and in industrial chemistry. With the information to help you perform very difficult separations of complex samples, this reference includes chapters contributed by leading experts or teams of experts.


Dietary Supplement Test Methods: Liquid Chromatography Separation Techniques And Application

Dietary Supplement Test Methods: Liquid Chromatography Separation Techniques And Application

Author: David Dajing Ji

Publisher: World Scientific

Published: 2022-04-21

Total Pages: 498

ISBN-13: 9811249261

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This book describes the analytical approach to testing over 160 important dietary supplement ingredients. In addition to the methods, there is significant guidance provided on how to develop, modify, and improve testing techniques. The procedures in this book include some of the most modern technologies that are available in the laboratory today. These basic principles of method development and troubleshooting can be implemented for food and food safety testing, drug development research, and agricultural areas. The contents of this book contain a very comprehensive collection of valuable analytical tools.