Hplc Method Development For Pharmaceuticals
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Hplc Method Development For Pharmaceuticals
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2011-09-21
Hplc Method Development For Pharmaceuticals written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-21 with Medical categories.
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
An Introduction To Hplc For Pharmaceutical Analysis
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Author : Oona McPolin
language : en
Publisher: Lulu.com
Release Date : 2009-03-01
An Introduction To Hplc For Pharmaceutical Analysis written by Oona McPolin and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-01 with Medical categories.
If you are new to HPLC, this book provides an invaluable guide to how HPLC is actually used when analysing pharmaceuticals. It is full of practical advice on the operation of HPLC systems combined with the necessary theoretical knowledge to ensure understanding of the technique. Key features include: A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe a HPLC column; Practical advice and helpful hints for the preparation and use of mobile phase; A complete overview of each of the different components which together make up a HPLC system; A description of the contents of a typical HPLC analytical method and how to interpret these; A step-by-step guide on how to follow a method and set up a HPLC analysis; A discussion of system suitability criteria and how to interpret the values obtained during an analysis; Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.
Hplc For Pharmaceutical Scientists
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Author : Yuri V. Kazakevich
language : en
Publisher: John Wiley & Sons
Release Date : 2007-02-16
Hplc For Pharmaceutical Scientists written by Yuri V. Kazakevich and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-16 with Science categories.
HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.
Analytical Method Development And Validation
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Author : Michael E. Swartz
language : en
Publisher: CRC Press
Release Date : 2018-10-03
Analytical Method Development And Validation written by Michael E. Swartz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-03 with Science categories.
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.
Handbook Of Pharmaceutical Analysis By Hplc
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Author : Satinder Ahuja
language : en
Publisher: Elsevier
Release Date : 2005-02-09
Handbook Of Pharmaceutical Analysis By Hplc written by Satinder Ahuja and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-02-09 with Medical categories.
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Hplc Method Development For Pharmaceuticals Vol 8 Hb
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Author : Ahuja
language : en
Publisher:
Release Date : 2009-01-01
Hplc Method Development For Pharmaceuticals Vol 8 Hb written by Ahuja and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-01-01 with categories.
Hplc Methods For Recently Approved Pharmaceuticals
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Author : George Lunn
language : en
Publisher: John Wiley & Sons
Release Date : 2005-05-06
Hplc Methods For Recently Approved Pharmaceuticals written by George Lunn and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-05-06 with Science categories.
An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods
Modern Hplc For Practicing Scientists
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Author : Michael W. Dong
language : en
Publisher: John Wiley & Sons
Release Date : 2016-04-06
Modern Hplc For Practicing Scientists written by Michael W. Dong and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-06 with Science categories.
A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.
Development Of Novel Stability Indicating Methods Using Liquid Chromatography
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Author : Mukesh Maithani
language : en
Publisher: Springer
Release Date : 2019-08-07
Development Of Novel Stability Indicating Methods Using Liquid Chromatography written by Mukesh Maithani and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-07 with Medical categories.
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.
Hplc Method For Determination Of Apis In Pharmaceutical Formulation
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Author : Parimal Chatrabhuji
language : en
Publisher: Lulu.com
Release Date : 2015-04-17
Hplc Method For Determination Of Apis In Pharmaceutical Formulation written by Parimal Chatrabhuji and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-17 with Science categories.
The idea for writing this basic HPLC book was probably born during the project sanctioned by University Grants Commission - Pune. This book was written as an updated reference guide for busy laboratory analysts and researchers. Topics covered include HPLC operation, method development and validation aspects. This book can serve as a supplementary text for students pursuing a career in analytical chemistry. It describes basic theories and terminologies for the novice and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. A reader with a science degree and a basic understanding of chemistry is assumed.