Chromatographic Methods Development

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Chromatographic Methods Development

Gregory K. Webster,Laila Kott
Chromatographic Methods Development Book PDF

Author : Gregory K. Webster,Laila Kott
Publisher : CRC Press
Page : 567 pages
File Size : 46,7 Mb
Release : 2019-10-28
Category : Medical
ISBN : 9780429510397

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Chromatographic Methods Development by Gregory K. Webster,Laila Kott Pdf

This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods (such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.

Practical HPLC Method Development

Lloyd R. Snyder,Joseph J. Kirkland,Joseph L. Glajch
Practical HPLC Method Development Book PDF

Author : Lloyd R. Snyder,Joseph J. Kirkland,Joseph L. Glajch
Publisher : John Wiley & Sons
Page : 665 pages
File Size : 54,8 Mb
Release : 2012-12-03
Category : Science
ISBN : 9781118591512

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Practical HPLC Method Development by Lloyd R. Snyder,Joseph J. Kirkland,Joseph L. Glajch Pdf

This revision brings the reader completely up to date on the evolving methods associated with increasingly more complex sample types analyzed using high-performance liquid chromatography, or HPLC. The book also incorporates updated discussions of many of the fundamental components of HPLC systems and practical issues associated with the use of this analytical method. This edition includes new or expanded treatments of sample preparation, computer assisted method development, as well as biochemical samples, and chiral separations.

Validating Chromatographic Methods

David M. Bliesner
Validating Chromatographic Methods Book PDF

Author : David M. Bliesner
Publisher : John Wiley & Sons
Page : 301 pages
File Size : 47,5 Mb
Release : 2006-09-11
Category : Science
ISBN : 9780470042199

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Validating Chromatographic Methods by David M. Bliesner Pdf

All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.

Biochemical Analysis Tools

Oana-Maria Boldura,Cornel Balta,Prof Nasser Awwad
Biochemical Analysis Tools Book PDF

Author : Oana-Maria Boldura,Cornel Balta,Prof Nasser Awwad
Publisher : BoD – Books on Demand
Page : 207 pages
File Size : 43,8 Mb
Release : 2020-06-24
Category : Science
ISBN : 9781789848564

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Biochemical Analysis Tools by Oana-Maria Boldura,Cornel Balta,Prof Nasser Awwad Pdf

This book explores the role of nucleic acid analysis and the advances it has led to in the field of life sciences. The first section is a collection of chapters covering experimental methods used in molecular biology, the techniques adjacent to these methods, and the steps of analysis before and after obtaining raw DNA data. The second section deals with the principles of chromatography, method development, sample preparation, and industrial applications.

Software-assisted Method Development In High Performance Liquid Chromatography

Szabolcs Fekete,Imre Molnar
Software assisted Method Development In High Performance Liquid Chromatography Book PDF

Author : Szabolcs Fekete,Imre Molnar
Publisher : World Scientific
Page : 364 pages
File Size : 49,9 Mb
Release : 2018-08-01
Category : Science
ISBN : 9781786345479

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Software-assisted Method Development In High Performance Liquid Chromatography by Szabolcs Fekete,Imre Molnar Pdf

'The book is a useful contribution in the field of HPLC, and may represent a valuable tool for chromatography practitioners in different fields, as well as teachers and instructors. The 12 chapters provide comprehensive insights of current day retention and resolution modelling in HPLC, and its applications for small and large molecule analysis. It may be a useful reference for specialists in pharmaceuticals but not limited to … It may be a valuable resource to assist scientists involved in method development, aiming to achieve the best results with reduced costs, time, and efforts.'Analytical and Bioanalytical ChemistryThis handbook gives a general overview of the possibilities in recent developments in chromatographic retention modeling. As a result of the latest developments in modeling software, several new features are now accessible, opening a new level in HPLC method development.Many of these current possibilities in software assisted liquid chromatographic method modeling for analytical purposes are presented. Several modes of chromatography, including Reversed-Phase Liquid Chromatography (RPLC), Ion Exchange Chromatography (IEX), Hydrophobic Interaction Chromatography (HIC), and Hydrophilic Interaction Liquid Chromatography (HILIC) are explained in detail. For all these chromatographic modes, the most important variables for tuning retention and selectivity are exposed.Beside the industrial and practical benefits of retention modeling, the possibilities in teaching and education are also illustrated. Finally, numerous representative industrial examples are shown, to highlight the benefits, time and cost savings offered by state-of-the-art software assisted HPLC method development.

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques

Satish Y. Gabhe
Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations HPLC And HPTLC Techniques Book PDF

Author : Satish Y. Gabhe
Publisher : diplom.de
Page : 108 pages
File Size : 52,7 Mb
Release : 2015-08-01
Category : Science
ISBN : 9783954898077

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Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques by Satish Y. Gabhe Pdf

This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.

Optimization of Chromatographic Selectivity

P.J. Schoenmakers
Optimization of Chromatographic Selectivity Book PDF

Author : P.J. Schoenmakers
Publisher : Elsevier
Page : 344 pages
File Size : 50,5 Mb
Release : 1986-08-01
Category : Science
ISBN : 0080858384

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Optimization of Chromatographic Selectivity by P.J. Schoenmakers Pdf

This is the first detailed description of method development in chromatography - the overall process of which may be summarized as: method selection, phase selection, selectivity optimization, and system optimization. All four aspects receive attention in this book. Chapter 1 gives a short introduction, describes chromatographic theory and nomenclature, and outlines the method development process. Chapter 2 describes guidelines for method selection, and quantitative concepts for characterizing and classifying chromatographic phases. Selective separation methods, from both gas and liquid chromatography are given in Chapter 3; the main parameters of each method are identified and simple, quantitative relations are sought to describe their effects. Criteria by which to judge the quality of separation are discussed in Chapter 4 with clear recommendations for different situations. The specific problems involved in the optimization of chromatographic selectivity are explained in Chapter 5. Optimization procedures, illustrated by examples, are extensively described and compared on the basis of a number of criteria. Suggestions are made both for the application of different procedures and for further research. The optimization of programmed analysis receives special attention in Chapter 6, and the last chapter summarizes the optimization of the chromatographic system, including the optimization of the efficiency, sensitivity and instrumentation. Those involved in developing chromatographic methods or wishing to improve existing methods will value the detailed, structured way in which the subject is presented. Because optimization procedures and criteria are described as elements of a complete optimization package, the book will help the reader to understand, evaluate and select current and future commercial systems.

HPLC Method Development for Pharmaceuticals

Satinder Ahuja,Henrik Rasmussen
HPLC Method Development for Pharmaceuticals Book PDF

Author : Satinder Ahuja,Henrik Rasmussen
Publisher : Elsevier
Page : 532 pages
File Size : 45,8 Mb
Release : 2011-09-21
Category : Medical
ISBN : 9780080554198

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HPLC Method Development for Pharmaceuticals by Satinder Ahuja,Henrik Rasmussen Pdf

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

Principles and Practice of Modern Chromatographic Methods

Kevin Robards,P. E. Jackson,Paul A. Haddad
Principles and Practice of Modern Chromatographic Methods Book PDF

Author : Kevin Robards,P. E. Jackson,Paul A. Haddad
Publisher : Elsevier
Page : 509 pages
File Size : 48,5 Mb
Release : 2012-12-02
Category : Science
ISBN : 9780080571782

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Principles and Practice of Modern Chromatographic Methods by Kevin Robards,P. E. Jackson,Paul A. Haddad Pdf

Though many separation processes are available for use in todays analytical laboratory, chromatographic methods are the most widely used. The applications of chromatography have grown explosively in the last four decades, owing to the development of new techniques and to the expanding need of scientists for better methods of separating complex mixtures. With its comprehensive, unified approach, this book will greatly assist the novice in need of a reference to chromatographic techniques, as well as the specialist suddenly faced with the need to switch from one technique to another.

Chromatographic Methods in Metabolomics

Tuulia Hyotylainen,Susanne Wiedmer
Chromatographic Methods in Metabolomics Book PDF

Author : Tuulia Hyotylainen,Susanne Wiedmer
Publisher : Royal Society of Chemistry
Page : 350 pages
File Size : 46,5 Mb
Release : 2013-09-06
Category : Science
ISBN : 9781849737272

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Chromatographic Methods in Metabolomics by Tuulia Hyotylainen,Susanne Wiedmer Pdf

The concept of a metabolic profile was introduced in 1971, when gas chromatography demonstrated a range of compounds present in human samples. Now termed metabolomics, the field is still emerging, and chromatography remains an essential tool for determining metabolites in a living system. This is the first book to present the chromatographic techniques used in metabolomics in a fundamental way. Sample preparation and quality control are described in detail, and all forms of chromatography applied to metabolomics are included. The editors present guidelines on selecting the most appropriate methodology, making the book an accessible guide to anyone entering the field. Handling data and applications are also described. This is an essential handbook for any laboratory looking to embark on a metabolomics research programme and includes the fundamentals of chromatography alongside the latest developments in the field.

Analytical Method Development and Validation

Michael E. Swartz
Analytical Method Development and Validation Book PDF

Author : Michael E. Swartz
Publisher : Unknown
Page : 92 pages
File Size : 51,7 Mb
Release : 1997
Category : High performance liquid chromatography
ISBN : 1315275163

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Analytical Method Development and Validation by Michael E. Swartz Pdf

"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."--Provided by publisher.

Chromatographic Methods

A. Braithwaite
Chromatographic Methods Book PDF

Author : A. Braithwaite
Publisher : Springer Science & Business Media
Page : 422 pages
File Size : 50,8 Mb
Release : 2012-12-06
Category : Science
ISBN : 9789400940932

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Chromatographic Methods by A. Braithwaite Pdf

In recent years the techniques of chromatography have progressed rapidly. However, the aims and objectives of the First Edition, as quoted below, are just as relevant today as they undoubtedly were in 1963. 'The various methods of separating mixtures which are grouped under the general name chromatography are now well known and widely used. Since the inception of chromatography as a column technique in 1903, the principal landmarks in its progress have been its virtual rediscovery in the 1930s, the invention of synthetic resins in 1935, the introduction of paper chromatography in the early 1940s and finally, the development of gas solid and gas liquid chromatography in the late 1940s and early 1950s. Subsequent expansion in the use of chromatographic methods has been rapid and continuous, with the result that in the last 15 years a substantial volume of literature on the subject has appeared, dealing not only with particular separations but also in much specific detail with improvements in technique.

Analytical and Chromatographic Techniques in Radiopharmaceutical Chemistry

Donald M. Wieland,Michael C. Tobes,Thomas J. Mangner
Analytical and Chromatographic Techniques in Radiopharmaceutical Chemistry Book PDF

Author : Donald M. Wieland,Michael C. Tobes,Thomas J. Mangner
Publisher : Springer Science & Business Media
Page : 305 pages
File Size : 40,8 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461248545

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Analytical and Chromatographic Techniques in Radiopharmaceutical Chemistry by Donald M. Wieland,Michael C. Tobes,Thomas J. Mangner Pdf

In 1906, Michael T. Sweet first developed the chromatographic method by using an adsorbant to separate pigments. Since that time, the technological advances in TLC and HPLC have brought about new definitions of purity in parallel with the advances. Radiopharmaceutical chemistry is especially dependent on the chromat ographic technique because of the relatively small amount of material in most radiopharmaceuticals-often so small that the usual physical methods of analytical chemistry cannot be used. As a result, this collection of papers represents the key to successful radiopharmaceutical development by setting the standard for the pres of radiochemical purity. ent-day definition William C. Eckelman, Ph.D. Diagnostics Associate Director The Squibb Institute for Medical Research New Brunswick, New Jersey Preface The chapters herein are updated and expanded versions of presentations that the authors made at a symposium held on June 4, 1984 in Los Angeles, California under the sponsorship of the Radiopharmaceutical Science Council of the Society of Nuclear Medicine. All manuscripts were refereed. The intent of the symposium organizers was to enlist participants who work on a day-to-day basis with the analytical and chromatographic techniques to be discussed at the symposium. We feel confident that this distillation of hands-on experience will be of value to graduate students as well as experienced researchers in radio pharmaceutical chemistry and related fields which use radiotracer methodology.

High-Temperature Liquid Chromatography

Thorsten Teutenberg
High Temperature Liquid Chromatography Book PDF

Author : Thorsten Teutenberg
Publisher : Royal Society of Chemistry
Page : 220 pages
File Size : 41,5 Mb
Release : 2010-06-03
Category : Science
ISBN : 9781849731096

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High-Temperature Liquid Chromatography by Thorsten Teutenberg Pdf

High-temperature liquid chromatography has attracted much interest in recent years but has not yet recognized its full potential in the chromatographic community. There is a widespread reluctance in industry to use temperature to speed up the separation process, influence the selectivity of a separation or implement novel detection techniques. However, the technology has now matured and could revolutionize chromatography as we see it today. Better equipment, such as heating systems able to generate faster heating rates, is becoming more readily available. Also, columns based on silica gel, which can withstand higher temperatures for an extended period, are now being introduced. Nevertheless, further technological and methodical efforts are needed to establish the method in a regulated environment like the pharmaceutical industry. This is the only text to cover all the practical aspects, as well as the underlying theoretical principles, of setting up an HPLC system for high temperature operation. It is not intended solely for academics but will also benefit the researcher interested in more practical considerations. The author is a recognized expert and has conducted several studies with partners from industry to validate the method. Many real examples from these studies have been included in the book. The aim is to support practitioners in the creation of their own protocols without the need to rely solely on trial and error. The book starts with a brief definition of high temperature liquid chromatography before going on to cover: system set up; the heating system; mobile phase considerations; suitable stationary phases; method development using temperature programming; analyte stability, and special hyphenation techniques using superheated water as a mobile phase. In each chapter, experimental data is used to illustrate the main statements and the advantages over conventional HPLC are evaluated. The book concludes with a critical outlook on further developments and applications underlining the necessary advances needed to make high temperature HPLC more robust.

Method Development,validation & Types of High Performance Liquid Chromatography

Afiya Ansari
Method Development validation Types of High Performance Liquid Chromatography Book PDF

Author : Afiya Ansari
Publisher : Createspace Independent Publishing Platform
Page : 50 pages
File Size : 55,6 Mb
Release : 2017-02-14
Category : Electronic
ISBN : 1543104355

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Method Development,validation & Types of High Performance Liquid Chromatography by Afiya Ansari Pdf

Chromatography may be defined as a nondestructive procedure for separating mixture of components into individual components through equilibrium distribution between two phases. The technique of chromatography is based on the differences in the rate at which the components of a mixture move through a porous medium under the influence of solvent or gas. The importance of Chromatography is increasing rapidly in pharmaceutical analysis in exact differentiation, selective identification and quantitative determination of structurally closely related compounds. Another important field of application of chromatographic methods is the purity testing of final products and intermediates (detection of decomposition products and by-products). As a consequence of the above points, chromatographic methods are occupying an ever-expanding position in the latest editions of the pharmacopoeias and other testing standards. Chromatography is one of the most powerful and versatile analytical techniques available to the modern chemist. Its power arises from its capacity to determine quantitatively many individual components present in a mixture in a one single analytical run. Its versatility comes from its capacity to handle wide variety of samples that may be gaseous, liquid or solid in nature. The sample can range in complexity from a single substance to a multicomponent mixture containing widely different chemical species. Another aspect of versatility is that the analysis can be carried out on a very costly complex instrument and on the other hand on a simple inexpensive thin layer plate. The modern form of column chromatography has been called high performance, high pressure, High resolution and high speed liquid chromatography. High Performance Liquid Chromatography (HPLC) is a special branch of column chromatography in which the mobile phase is forced through the column at high speed. As a result the analysis time is reduced by 1-2 orders of magnitude relative to classical column chromatography and the use of much smaller particles of the adsorbent or support becomes possible increasing the column efficiency substantially.