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).


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© 2005
Academic Press
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About the editors

Satinder Ahuja

Satinder Ahuja earned his PhD in analytical chemistry from the University of the Sciences, Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years while simultaneously teaching and guiding research as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on quality issues relating to chemicals/pharmaceuticals and water. Dr. Ahuja has published numerous papers and more than eighteen books. Two of his latest books are entitled "Water Reclamation and Sustainability" (Elsevier) and Comprehensive "Water Quality and Purification" (Elsevier). Others include "Monitoring Water Quality: Pollution Assessment, Analysis, and Remediation" (Elsevier, 2013); "Novel Solutions to Water Pollution" (ACS Symposium Volume, 2013); "Handbook of Water Purity and Quality" (Elsevier, 2009); and "Arsenic Contamination of Water: Mechanism, Analysis, and Remediation" (Wiley, 2008). A member of the executive committee of Rivers of the World Foundation (ROW), Dr. Ahuja is an expert on improving water quality and has organized numerous global symposia on this topic (American Chemical Society, UNESCO, etc.) In 2013, he gave a lecture on the nexus of food, energy, and water and chaired a symposium on the subject for the American Chemical Society meeting in New Orleans.

Affiliations and Expertise

Ahuja Consulting, Calabash, NC, USA

Michael Dong

Affiliations and Expertise

Purdue Pharma, Ardsley, NY, USA