HPLC Methods for Recently Approved Pharmaceuticals (George Lunn & Wiley Interscience) (2005)

HPLC Methods for Recently Approved Pharmaceuticals (George Lunn & Wiley Interscience) (2005)

This book is a collection of procedures for the analysis of more than 390 pharmaceuticals using high-performance liquid chromatography (HPLC) and covers the literature up to the end of 2003. The current volume is a continuation of HPLC Methods for Pharmaceutical Analysis, published in four volumes from 1997 to 2000. The previous volumes described methods published in the literature through the middle of 1998.

The current work lists procedures for the analysis of drugs in three broad categories:

  • Drugs that have been approved since the previous volumes were published.
  • Drugs that were approved when the previous volumes were published but for which analytical methods were not then available in the literature.
  • Drugs for which procedures allowing determination in a blood matrix have only become available since the previous volumes were published.

Please note that mention of a drug does not necessarily mean that it is currently approved for use in the United States or indeed in any country.

Despite the ready availability of computer-aided literature, searching this resource is not exploited as much as it might be. One reason for this reluctance is, of course, that a computer search merely produces a listing of possibly relevant references. Tedious and time-consuming searches in the library are necessary to find the most relevant reference that can be turned into a practical analytical procedure in the searcher’s own laboratory. The reference finally chosen will, naturally, depend on the individual circumstances, such as the matrix in which the drug is present, availability of equipment, and so on. This book circumvents this lengthy process by providing a number of abstracted and evaluated procedures for the analysis of each drug. The analyst can rapidly identify a relevant procedure and put it into practice.

In addition to the analytical matrix, other factors may be important when choosing an analytical procedure. Accordingly, we have noted such features of the analytical procedures as sensitivity, mode of detection, other compounds that interfere with the analysis, other drugs that may be determined at the same time, and so on.

Readers familiar with our previous publications, HPLC Methods for Pharmaceutical Analysis, Volumes 1–4 (George Lunn and Norman R. Schmuff, John Wiley, New York, 1997–2000) and Handbook of Derivatization Reactions for HPLC (George Lunn and Louise C. Hellwig, John Wiley, New York, 1998), will notice many similar-ities. The abstract structure is very similar, and the philosophy that the procedures

should be reproducible without reference to the original literature is unchanged. A new feature is that the retention times (in minutes) of other drugs that may be determined using the same system have been added in parentheses after the drug name. Other data, such as the limit of detection (LOD), may also be added. The retention time is the number without units. Unlike the previous volumes, this book is not available on a CD in an electronic form.

At the end of the book a Cumulative Index and a Cross-Index to Other Substances are provided. The Cumulative Index provides a comprehensive listing of the drugs covered in this book and the previous volumes. The Cross-Index lists the other compounds that may also be chromatographed under the conditions described in the monographs in this book. Using the information in the monographs it may be possible to develop chromatographic procedures for these compounds.

Newly approved drugs were identified from a variety of sources including the FDA’s annual lists of drug approvals (available at www.fda.gov/cder) and Annual Reports in Medicinal Chemistry published by Elsevier/Academic Press.

The journals routinely surveyed for relevant articles are:

The journals routinely surveyed for relevant articles are:
American Journal of Health-System Pharmacy
Analytica Chimica Acta
Analytical Chemistry
Analytical Letters
Analytical Sciences
Antimicrobial Agents and Chemotherapy Arzneimittelforschung
Biological and Pharmaceutical Bulletin
Biomedical Chromatography
Biopharmaceutics and Drug Disposition
Chemical and Pharmaceutical Bulletin Chromatographia
Clinical Chemistry
Clinical Pharmacology and Therapeutics
Drug Metabolism and Disposition
Food Additives and Contaminants
Journal of Analytical Toxicology
Journal of AOAC International
Journal of Chromatographic Science
Journal of Chromatography, Part A and Part B Journal of Clinical Pharmacology
Journal of Forensic Sciences
Journal of Liquid Chromatography & Related Technology Journal of Pharmaceutical and Biomedical Analysis Journal of Pharmaceutical Sciences
Journal of Pharmacology and Experimental Therapeutics Pharmaceutical Research
Therapeutic Drug Monitoring

Other journals were consulted when relevant articles were identified by com-puter searches.
The literature was surveyed from 1998 through the end of 2003, although methods from some older articles (and a few from 2004) are included.
Each chapter is headed by the name and structure of the target compound as well as other useful data such as the CAS Registry Number, molecular formula, molecular weight, and Merck Index number (from the 13th edition).1 More useful information such as melting point, solubility, optical rotation, references to reviews, and so on can be found in the Merck Index.
In general, the United States Adopted Name (USAN)2 is used throughout to identify each drug. Names of derivatives, such as esters, which would have differ-ent chromatographic properties, are identified by placing the derivative name in parentheses after the retention time.
Increasingly, drugs previously marketed as racemates are being marketed as a single enantiomer with the name changed to reflect the enantiomer. For example, levofloxacin is the levorotatory form of ofloxacin. For an achiral HPLC method, the chromatography of a single enantiomer is no different from that of the racemate. In general, in this work and the preceding works, we have listed HPLC procedures under the name of the racemate rather than the single enantiomer. The interested reader is referred to the USP Dictionary2 (page 1208) for the naming conventions used. Generally:

Levo rotatory          S isomer   Prefix lev/levo-
Levo rotatory          R isomer   Prefix ar-
Dextro rotatory       R isomer   Prefix dex/dextro-
Dextro rotatory       S isomer   Prefix es-

For racemates, the rac- prefix is used.
In some cases, the chiral prefix is used. Thus, the following list shows the prefixes that are used in the different volumes:

Dexrazoxane in this volume
Dextromethorphan in Volume 2
Dextromoramide in Volume 2
Dextrothyroxine in Volume 2
Levallorphan in Volume 3
Levamisole in Volume 3
Levobunolol in Volume 3
Levodopa in Volume 3
Levonordefrin in Volume 3 and this volume
Levorphanol in Volume 3
Levosimendan in this volume
Levothyroxine in Volumes 1 and 3.


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