HPLC Method Development for Pharmaceuticals

HPLC Method Development for Pharmaceuticals

Author: Satinder Ahuja

Publisher: Elsevier

Published: 2011-09-21

Total Pages: 533

ISBN-13: 0080554199

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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


HPLC in Clinical Chemistry

HPLC in Clinical Chemistry

Author: Papadoyannis

Publisher: CRC Press

Published: 1990-06-19

Total Pages: 510

ISBN-13: 9780824781392

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Based on the use of high-performance liquid chromatography (HPLC) as a means to assess quantities of separated components in HPLC detectors, this volume is structured for use by analysts who have some experience in chemical analysis or have done HPLC. It keeps theory and instrumentation at a minimum


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


The HPLC Solvent Guide

The HPLC Solvent Guide

Author: Paul Charles Sadek

Publisher: John Wiley & Sons

Published: 2002-02-27

Total Pages: 670

ISBN-13:

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High-performance liquid chromatography (HPLC) is a procedure for separating components from a mixture of chemical substances; a combination of separation, identification, and quantitative measurements. Solvent selection is perhaps the most commonly overlooked parameter in HPLC. Even the most experienced analytical chemist tends to select one of three familiar solvents. The HPLC Solvent Guide provides detailed coverage of all commonly used HPLC solvents used in a wide range of separations. HPLC is a mature but substantial market, and one that Wiley reaches successfully and well. The HPLC list is established, and this second edition of a successful title will build upon the success of the first. This is a revised and expanded edition in a field that is still growing into areas of analysis and methods.


Separation Techniques in Clinical Chemistry

Separation Techniques in Clinical Chemistry

Author: Hassan Y. Aboul-Enein

Publisher: CRC Press

Published: 2003-05-28

Total Pages: 671

ISBN-13: 1135532788

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This reference examines innovations in separation science for improved sensitivity and cost-efficiency, increased speed, higher sample throughput and lower solvent consumption in the assessment, evaluation, and validation of emerging drug compounds. It investigates breakthroughs in sample pretreatment, HPLC, mass spectrometry, capillary electrophor


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.


HPLC

HPLC

Author: Toshihiko Hanai

Publisher: Royal Society of Chemistry

Published: 1999

Total Pages: 152

ISBN-13: 9780854045150

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How can these compounds be separated? Why was that method used? These are the two basic questions often asked by students of chromatography. HPLC: A Practical Guide provides the answers, enabling the reader to grasp the concepts of the technique using simple, representative chromatograms. Divided into six chapters, this practical guide covers basic concepts of HPLC; instrumentation; stationary phase materials; eluents; column efficiency; and the influence of physical chemistry on separations. Focusing on the basic considerations such as selection of stationary phase and eluent, rather than specific applications, sections on troubleshooting are also included. Uniquely, the descriptions of chromatographic separations are based on solubility using molecular properties, and solubility parameters are used to analyse the selections of chromatographic mode and column. Presenting the chemistry of liquid chromatography for undergraduate students, this valuable practical guide will also be useful for laboratory staff in industry and academia.


HPLC

HPLC

Author: Joel K. Swadesh

Publisher: CRC Press

Published: 2000-12-21

Total Pages: 480

ISBN-13: 1420042661

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Product specifications, regulatory constraints, and tight production schedules impose considerable pressures on separation scientists in industry. The first edition of HPLC: Practical and Industrial Applications helped eliminate the need for extensive library or laboratory research when confronting a problem, an unfamiliar technique, or work in a n


Practical HPLC Method Development

Practical HPLC Method Development

Author: Lloyd R. Snyder

Publisher: John Wiley & Sons

Published: 2012-12-03

Total Pages: 665

ISBN-13: 1118591518

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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.