HPLC Methods for Clinical Pharmaceutical Analysis

HPLC Methods for Clinical Pharmaceutical Analysis

Author: Hermann Mascher

Publisher: John Wiley & Sons

Published: 2012-02-13

Total Pages: 0

ISBN-13: 3527331298

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Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind


HPLC Methods for Pharmaceutical Analysis, Volumes 2-4

HPLC Methods for Pharmaceutical Analysis, Volumes 2-4

Author: George Lunn

Publisher: Wiley-Interscience

Published: 2000-01-21

Total Pages: 0

ISBN-13: 9780471332961

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The most commonly used method for analyzing substances, and the first method most researchers turn to, is high performance liquid chromatography (HPLC). Following up on a best-seller, volumes 2-4 continue to provide an easily-accessible collection of procedures for analyzing pharmaceuticals using HPLC.


HPLC for Pharmaceutical Scientists

HPLC for Pharmaceutical Scientists

Author: Yuri V. Kazakevich

Publisher: John Wiley & Sons

Published: 2007-02-16

Total Pages: 1136

ISBN-13: 0470087943

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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.


Validation of Analytical Methods for Pharmaceutical Analysis

Validation of Analytical Methods for Pharmaceutical Analysis

Author: Oona McPolin

Publisher: Lulu.com

Published: 2009-05-01

Total Pages: 154

ISBN-13: 0956152813

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This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.


HPLC in the Pharmaceutical Industry

HPLC in the Pharmaceutical Industry

Author: Godwin W. Fong

Publisher: CRC Press

Published: 1991-03-14

Total Pages: 332

ISBN-13: 9780824784997

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A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an


Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification

Author: Chung Chow Chan

Publisher: John Wiley & Sons

Published: 2004-04-23

Total Pages: 320

ISBN-13: 047146371X

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Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.


Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC

Author: Satinder Ahuja

Publisher: Elsevier

Published: 2005-02-09

Total Pages: 679

ISBN-13: 0080455182

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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


Modern HPLC for Practicing Scientists

Modern HPLC for Practicing Scientists

Author: Michael W. Dong

Publisher: John Wiley & Sons

Published: 2016-04-06

Total Pages: 285

ISBN-13: 111929360X

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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.


Pharmaceutical Analysis E-Book

Pharmaceutical Analysis E-Book

Author: David G. Watson

Publisher: Elsevier Health Sciences

Published: 2015-12-24

Total Pages: 598

ISBN-13: 0702069884

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Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on electrochemical biosensors. New chapter on the quality control of biotechnologically produced drugs. Extended chapter on molecular emission spectroscopy. Now comes with an e-book on StudentConsult. Self-assessment is interactive in the accompanying online e-book. 65 online animations show concepts such as ionization partitioning of drug molecules etc. ~


Analytical Techniques for Clinical Chemistry

Analytical Techniques for Clinical Chemistry

Author: Sergio Caroli

Publisher: John Wiley & Sons

Published: 2012-06-26

Total Pages: 37

ISBN-13: 111827184X

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Discover how analytical chemistry supports the latest clinical research This book details the role played by analytical chemistry in fostering clinical research. Readers will discover how a broad range of analytical techniques support all phases of clinical research, from early stages to the implementation of practical applications. Moreover, the contributing authors' careful step-by-step guidance enables readers to better understand standardized techniques and steer clear of everyday problems that can arise in the lab. Analytical Techniques for Clinical Chemistry opens with an overview of the legal and regulatory framework governing clinical lab analysis. Next, it details the latest progress in instrumentation and applications in such fields as biomonitoring, diagnostics, food quality, biomarkers, pharmaceuticals, and forensics. Comprised of twenty-five chapters divided into three sections exploring Fundamentals, Selected Applications, and Future Trends, the book covers such critical topics as: Uncertainty in clinical chemistry measurements Metal toxicology in clinical, forensic, and chemical pathology Role of analytical chemistry in the safety of drug therapy Atomic spectrometric techniques for the analysis of clinical samples Biosensors for drug analysis Use of X-ray techniques in medical research Each chapter is written by one or more leading pioneers and experts in analytical chemistry. Contributions are based on a thorough review and analysis of the current literature as well as the authors' own firsthand experiences in the lab. References at the end of each chapter serve as a gateway to the literature, enabling readers to explore individual topics in greater depth. Presenting the latest achievements and challenges in the field, Analytical Techniques for Clinical Chemistry sets the foundation for future advances in laboratory research techniques.