This is an excellent book for both novice and experienced pharmaceutical chemists that provides a unified approach to HPLC with a balanced treatment of the theory and practice of HPLC in the pharmaceutical industry.
The book spells out the role of HPLC throughout drug development process from drug discovery to quality control and manufacturing and gives detailed specifics of HPLC application in each stage of drug development.
The text also covers the latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography).
Here is a detailed review by Ira Krul from Northeastern University.
This is a very useful, very large, and practical text on the applications and utility of HPLC in the pharmaceutical and biotechnology industries. Its editors have many years of experience with HPLC, with Kazakevich teaching it at the academic level and LoBrutto applying it in industry. Together, they bring their expertise in the area to cover the fundamentals, theory, and applications of HPLC for pharmaceutical scientists.
There are 25 contributors and 22 chapters, which are broken down into three parts, the first of which covers the fundamentals and theory of HPLC and then the different modes most commonly practiced in the pharmaceutical industry, e.g., normal phase, reversed phase, size exclusion, etc. A chapter on LC/MS, perhaps the most important use of HPLC at the analytical level, and its application to small molecules follows. There are also chapters on method development, method validation, and computer/software-assisted HPLC and knowledge management, which make this text different from others on HPLC where such topics are not usually covered.
Part II is devoted to specific uses of HPLC in the pharmaceutical industry, such as the roles of HPLC in drug discovery, preformulation, process development, developing formulations, and technical transfer and manufacturing. The role of LC/MS in pharmacokinetics and drug metabolism is also covered.
Finally, hyphenated techniques and specialized HPLC separations are covered in Part III. This last section includes discussion of the following topics: development of fast HPLC methods, temperature as a variable in pharmaceutical applications, LC/MS analysis of proteins and peptides in drug discovery, an overview of LC/NMR and pharmaceutical applications, preparative HPLC for pharmaceuticals, and, finally, chiral separations.
I was personally somewhat disappointed that the book did not devote more space and attention to the HPLC of larger molecules and applications involving biotech products. There is some discussion of HPLC of proteins and peptides but almost nothing on nucleic acids or carbohydrates and antibodies, although these are important areas in the practice of HPLC for biotechnology researchers. My main criticism of the overall text is that 90% of the material is devoted to small-molecule pharmaceuticals at a time when the biotech industry is booming throughout the world. Perhaps the next edition could introduce a third editor from this sector with experience, expertise, and familiarity with HPLC for biotech products.
The chapters are written by a potpourri of authors, whose writing styles and command of English vary. Although the editors are to be commended for selecting acknowledged experts in the areas covered, the book could have been improved by more thorough oversight of language and style. Still, the chapters flow very nicely from one to the next, and together they make a very cohesive and comprehensive volume, one that is well-rounded and pleasing overall. The total is indeed more than the sum of its parts.
The book is too long to digest in a few sittings and is not a simple text for any first course in instrumental analysis or analytical separations. Rather it would be most useful for practitioners of HPLC in the pharmaceutical/biotech industries or perhaps for those being trained for employment in such industries, such as part of an upper-level or graduate course in analytical separations.
In conclusion, I found the book extremely useful and quite extensive in its coverage of the subject matter. The authors are clearly knowledgeable, and they have written excellent overviews of each subject area, with very extensive, up-to-date literature coverage and citations. I highly recommend the book to those involved in or expecting to become involved with HPLC for the pharmaceutical and/or biotech industries.