In the modern pharmaceutical industry, high performance liquidchromatography (HPLC) is a major analytical tool applied in allstages of drug discovery, development, and production. Fastand effective development of rugged analytical HPLC separationmethods requires a thorough understanding of HPLC principles, theory, and instrumentation.

This book is written in three parts. The first part, GeneralHPLC Theory and Practice, covers the theory and current advances inHPLC retention mechanism; and the role of the column, mobile phase, and temperature in method selectivity and chromatographic retentionincluding practical applications. The second part, HPLC inthe Pharmaceutical Industry, discusses method developmentstrategies and method validation at various stages of the drugdevelopment process with emphasis on GMP (Good ManufacturingPractices) requirements, including practical applications. The final part, Hyphenated Techniques and Specialized HPLCSeparations, provides a selection of Special techniques such asLC-NMR, Preparative LC, and Chiral separations.

The new edition provides a broader coverage of important topics, such as determination of the analytical variability of methods, chromatographic separation of proteins and other biomolecules andsample preparation of finished product dosage forms and usage ofvarious detections systems to investigate mass balance duringforced degradation and stability testing which were limited in thefirst edition. Also, with the advent of Quality by Design (QbD), the workflow for quality QbD, and the application of QbD tochromatographic methods and sample preparation areincluded.