Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC

1st Edition - February 9, 2005

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  • Editors: Satinder Ahuja, Michael Dong
  • Hardcover ISBN: 9780120885473
  • eBook ISBN: 9780080455181

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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).

Key Features

  • 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


For laboratory analysts, researchers and managers in the pharmaceutical industry, academia and government agencies

Table of Contents

  • Overview (S. Ahuja).

    Key concepts of HPLC in pharmaceutical analysis (R.D. Ornaf, M. Dong).

    HPLC instrumentation: in pharmaceutical analysis: status, advances and trends (M. Dong).

    HPLC columns for pharmaceutical analysis (U. Neue et al.).

    Sample preparation for HPLC analysis of drug products (C.K. Choi, M.W. Dong).

    HPLC method development (H.T. Rasmussen et al.).

    Validation of HPLC methods in pharmaceutical analysis (A.S. Lister).

    Ion Chromatography (C. Pohl).

    How to be more successful with HPLC analysis:: practical aspects in HPLC operation (M.W. Dong).

    Regulatory considerations in HPLC anaysis (C.F. Richardson, F. Erni).

    HPLC system calibration for GMP compliance (M. Dong).

    System validation: pre-installation, IQ, OQ and PQ (W.M. Reuter).

    Assays and stability testing (A.W. Wong, A. Datla).

    Impurity evaluation (T. Cecil, E. Shenin).

    HPLC in dissolution testing (Q. Wang, V. Gray).

    Cleaning validation using HPCL for analysis (A. Plasz).

    LC/MS application in high throughput ADME screen (R. Kong).

    Chiral separations (Y. Vander Heyden et al.).

    Applications of LC/MS in pharmaceutical analysis (L.Z. Zhou).

    Application of LC-MMR in Pharmaceutical Analysis (M-H. Wann).

    Chromatography data systems (CDS) in the pharmaceutical laboratory; its history, advances and future direction (R. Mazzarese).

    New developments in HPLC (D.M. Wagrowski-Diehl, S. Ahuja).

Product details

  • No. of pages: 600
  • Language: English
  • Copyright: © Academic Press 2005
  • Published: February 9, 2005
  • Imprint: Academic Press
  • Hardcover ISBN: 9780120885473
  • eBook ISBN: 9780080455181

About the Editors

Satinder Ahuja

Satinder Ahuja
Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017).

Affiliations and Expertise

President, Ahuja Consulting for Water Quality, Calabash, NC, USA

Michael Dong

Affiliations and Expertise

Purdue Pharma, Ardsley, NY, USA

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