Chromatographic Methods Development

Author : Lloyd R. Snyder
Publisher : John Wiley & Sons
ISBN 13 : 1118591518
Total Pages : 665 pages
Book Rating : 4.12/5 ( download)

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Download or read book Practical HPLC Method Development written by Lloyd R. Snyder and published by John Wiley & Sons. This book was released on 2012-12-03 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Oana-Maria Boldura
Publisher : BoD – Books on Demand
ISBN 13 : 1789848563
Total Pages : 207 pages
Book Rating : 4.64/5 ( download)

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Download or read book Biochemical Analysis Tools written by Oana-Maria Boldura and published by BoD – Books on Demand. This book was released on 2020-06-24 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Gregory K. Webster
Publisher : CRC Press
ISBN 13 : 042951039X
Total Pages : 567 pages
Book Rating : 4.97/5 ( download)

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Download or read book Chromatographic Methods Development written by Gregory K. Webster and published by CRC Press. This book was released on 2019-10-28 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : David M. Bliesner
Publisher : John Wiley & Sons
ISBN 13 : 0470042192
Total Pages : 301 pages
Book Rating : 4.99/5 ( download)

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Download or read book Validating Chromatographic Methods written by David M. Bliesner and published by John Wiley & Sons. This book was released on 2006-09-11 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Satish Y. Gabhe
Publisher : diplom.de
ISBN 13 : 3954898071
Total Pages : 108 pages
Book Rating : 4.77/5 ( download)

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Download or read book Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques written by Satish Y. Gabhe and published by diplom.de. This book was released on 2015-08-01 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.76/5 ( download)

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Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 0080554199
Total Pages : 532 pages
Book Rating : 4.98/5 ( download)

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Download or read book HPLC Method Development for Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2011-09-21 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Serban C. Moldoveanu
Publisher : Elsevier
ISBN 13 : 0128037113
Total Pages : 598 pages
Book Rating : 4.19/5 ( download)

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Download or read book Selection of the HPLC Method in Chemical Analysis written by Serban C. Moldoveanu and published by Elsevier. This book was released on 2016-11-01 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: Selection of the HPLC Method in Chemical Analysis serves as a practical guide to users of high-performance liquid chromatography and provides criteria for method selection, development, and validation. High-performance liquid chromatography (HPLC) is the most common analytical technique currently practiced in chemistry. However, the process of finding the appropriate information for a particular analytical project requires significant effort and pre-existent knowledge in the field. Further, sorting through the wealth of published data and literature takes both time and effort away from the critical aspects of HPLC method selection. For the first time, a systematic approach for sorting through the available information and reviewing critically the up-to-date progress in HPLC for selecting a specific analysis is available in a single book. Selection of the HPLC Method in Chemical Analysis is an inclusive go-to reference for HPLC method selection, development, and validation. Addresses the various aspects of practice and instrumentation needed to obtain reliable HPLC analysis results Leads researchers to the best choice of an HPLC method from the overabundance of information existent in the field Provides criteria for HPLC method selection, development, and validation Authored by world-renowned HPLC experts who have more than 60 years of combined experience in the field

Author : Michal Holcapek
Publisher : Elsevier
ISBN 13 : 0128117338
Total Pages : 520 pages
Book Rating : 4.30/5 ( download)

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Download or read book Handbook of Advanced Chromatography /Mass Spectrometry Techniques written by Michal Holcapek and published by Elsevier. This book was released on 2017-09-07 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Advanced Chromatography /Mass Spectrometry Techniques is a compendium of new and advanced analytical techniques that have been developed in recent years for analysis of all types of molecules in a variety of complex matrices, from foods to fuel to pharmaceuticals and more. Focusing on areas that are becoming widely used or growing rapidly, this is a comprehensive volume that describes both theoretical and practical aspects of advanced methods for analysis. Written by authors who have published the foundational works in the field, the chapters have an emphasis on lipids, but reach a broader audience by including advanced analytical techniques applied to a variety of fields. Handbook of Advanced Chromatography / Mass Spectrometry Techniques is the ideal reference for those just entering the analytical fields covered, but also for those experienced analysts who want a combination of an overview of the techniques plus specific and pragmatic details not often covered in journal reports. The authors provide, in one source, a synthesis of knowledge that is scattered across a multitude of literature articles. The combination of pragmatic hints and tips with theoretical concepts and demonstrated applications provides both breadth and depth to produce a valuable and enduring reference manual. It is well suited for advanced analytical instrumentation students as well as for analysts seeking additional knowledge or a deeper understanding of familiar techniques. Includes UHPLC, HILIC, nano-liquid chromatographic separations, two-dimensional LC-MS (LCxLC), multiple parallel MS, 2D-GC (GCxGC) methodologies for lipids analysis, and more Contains both practical and theoretical knowledge, providing core understanding for implementing modern chromatographic and mass spectrometric techniques Presents chapters on the most popular and fastest-growing new techniques being implemented in diverse areas of research

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128203331
Total Pages : 225 pages
Book Rating : 4.30/5 ( download)

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Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance