Chromatographic Methods Development

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.

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.

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.

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.

'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.

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.

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.

Principles and Practice of Modern Chromatographic Methods, Second Edition takes a comprehensive, unified approach in its presentation of chromatographic techniques. Like the first edition, the book provides a scientifically rigid, but easy-to-follow presentation of chromatography concepts that begins with the purpose and intent of chromatographic theory - the “what and why that are left out of other books attempting to cover these principles. This fully revised second edition brings the content up-to-date, covering recent developments in several new sections and an additional chapter on composite methods. New topics include sample profiling, sample preparation, sustainable green chemistry, 2D chromatography, miniaturization/nano-LC, HILIC, and more. Contains thorough chapters that begin with an updated schematic overview and a visual representation of the content Avoids the obfuscation of different terminologies and classification systems that are prevalent in the area, such as the relationship between liquid chromatography and column chromatography Provides integrated and comprehensive topic coverage based on chromatographic bibliometrics and survey reports on the relative usage of chromatographic techniques