HPLC Methods for Clinical Pharmaceutical Analysis

The author describes all steps of a routine pharmaceutical analysis in an intuitive fashion and explains how to develop robust and efficient methods for any clinical compound. A reference appendix contains tried and tested methods for 100 freqently encountered pharmaceuticals.

Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of
experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them.

With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory,
complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for
everyone working in clinical, pharmaceutical and biochemical analysis.

Comments to the German book:
"The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't."
ChemieReport

"Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired."
pharmind

Auteur
Hermann Mascher is founder and CEO of the independent contract research organization "pharm-analyt" based in Baden (near Vienna), Austria. A chemist by training, he has been dealing with quantitative determination of drugs, metabolites, phyto-ingredients and endogenous substances in plasma, urine and tissue for more than 30 years. Professor Mascher is regularly being consulted for analytical questions
of drugs, food as well as botanical and ecological issues. He has published over 80 publications majorly in peer reviewed journals and received several awards in science and innovation for his work in the analysis of clinically important substances.

Contenu
Preface

INTRODUCTION
First Question: Determination of Ibuprofen in Plasma
Second Question: Determination of Tryptophan in Urine
Third Question: Determination of Paclitaxel in Tissue

PLANNING OF ANALYSES
Introduction
Limit of Detection (LOD) and Determination (LLOQ)
Detectors
Structure of the Analyte
Solubility of an Analyte
Selection of the Detector

SAMPLE PREPARATION
Dilution
Protein Precipitation, Overview
Extraction

HPLC SEPARATION
HPLC Pumps
Degassers
Injector
HPLC Columns

DETECTION
Detection in the Pharmaceutical/Bioanalytical Area
Detection in the "Clinical Area" (Therapy Control/Compliance)

CHEMICAL DERIVATISATION FOR DETECTION ENHANCEMENT

VALIDATION CONCEPTS
Introduction
Realisation of the FDA Guideline

PRACTICAL HINTS CONCERNING STABILITY, DESTRUCTION AND DEGRADATION PRODUCTS

METABOLITES

INTERNAL STANDARDS

CASE STUDIES WITH INTENSIVE DISCUSSION FOR EACH SUBSTANCE
Acetylcarnitine in Plasma
Acetylcysteine in Plasma
Acyclovir in Plasma and Urine
Caffeine in Plasma
Diazepam in Plasma
Diclofenac in Plasma
Dihydralazine in Plasma
Duramycin (Moli1901) in Plasma
Fluticasone Propionate in Plasma
Hydroxytriamterene Sulfate and Triamterene in Plasma and Urine
Ibuprofen in Plasma (also Enantiomeric Separation)
Minocycline in plasma
Norfloxacine in Plasma and Urine
Paclitaxel in Plasma, Urine, and Tissue
Paracetamol (Acetaminophen) in Plasma
Pimelic Acid in Plasma and Urine
8-Prenylnaringenin in Plasma and in Different Types of Tissues
Silibinin in Plasma
Valnemulin in Plasma, Different Tissue Types and Animal Feed
Vitamin B1 (Total Thiamine) in Plasma

APPENDIX
Short Description of Determination for about 100 Substances
Substances listed in the Appendix
A Short Explanation of Tables Presented in the Appendix