HPLC Methods for Clinical Pharmaceutical Analysis

  • ID: 2183397
  • Book
  • 256 Pages
  • John Wiley and Sons Ltd
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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
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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
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"The book is clearly written and comprehensive. A lot of practical advice and tips makes it helpful for any practically oriented clinical laboratory and it can be counted as a valuable source for everyone working with chromatographic techniques in a bioanalytical laboratory."  (Analytical and Bioanalytical Chemistry, 13 November 2012)

This book is more than a very successful and useful user guide, and is a valuable tool for the laboratorywork, not only for clinical analysts, but also for biochemists, pharmacists, etc. In addition to a compact targeted representation of the most important theoretical foundations for the planning and execution of (clinical) analysis (sample preparation, HPLC separation, usage of different modes, detection capabilities, derivatization techniques to the point of validation), the readers receive valuable information for their work, which are explained on the basis of practical examples [pages 1 64].   (ChemMedChem, 1 November 2012)

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