Handbook of Pharmaceutical Analysis by HPLC

Edited by

  • Satinder Ahuja, Ahuja Consulting, Calabash, NC, USA
  • Michael Dong, Purdue Pharma, Ardsley, NY, USA

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


Book information

  • Published: February 2005
  • ISBN: 978-0-12-088547-3

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).