Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.
A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, analyses of pharmaceuticals- helping readers meet rigorous regulatory agency standards for acceptable test results. Written by leading experts in the field, this text describes current liquid chromatographic techniques in pharamaceutical analysis...discusses highly sensitve detailed detection of drugs... considers automatation in pharamaceutical analysis...examines new molecular entities and opitcal isomers... and more.
Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.
Recent advances in the pharmaceutical sciences and biotechnology have facilitated the production, design, formulation and use of various types of pharmaceuticals and biopharmaceuticals. This book provides detailed information on the background, basic principles, and components of techniques used for the analysis of pharmaceuticals and biopharmaceuticals. Focusing on those analytical techniques that are most frequently used for pharmaceuticals, it classifies them into three major sections and 19 chapters, each of which discusses a respective technique in detail. Chiefly intended for graduate students in the pharmaceutical sciences, the book will familiarize them with the components, working principles and practical applications of these indispensable analytical techniques.
If you are new to HPLC, this book provides an invaluable guide to how HPLC is actually used when analysing pharmaceuticals. It is full of practical advice on the operation of HPLC systems combined with the necessary theoretical knowledge to ensure understanding of the technique. Key features include: A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe a HPLC column; Practical advice and helpful hints for the preparation and use of mobile phase; A complete overview of each of the different components which together make up a HPLC system; A description of the contents of a typical HPLC analytical method and how to interpret these; A step-by-step guide on how to follow a method and set up a HPLC analysis; A discussion of system suitability criteria and how to interpret the values obtained during an analysis; Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.
This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing. In addition, an appendix section gives information on critical physical and chromatographic parameters related to IC and information on current manufacturers of IC systems, columns, and other components.
Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods. Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.
Analytical chemists in the pharmaceutical industry are always looking for more-efficient techniques to meet the analytical challenges of today’s pharmaceutical industry. One technique that has made steady advances in pharmaceutical analysis is supercritical fluid chromatography (SFC). SFC is meeting the chromatography needs of the industry by providing efficient and selective testing capabilities on the analytical and preparative scale. The supercritical fluid mobile phase, consisting mainly of CO2, facilitates cost reduction costs and helps the industry in meeting green chemistry standards. This book provides a comprehensive overview of the use of SFC in pharmaceutical analysis. Supercritical Fluid Chromatography reviews the use of SFC in drug-discovery applications and describes its application in drug development. When a drug is developed and brought to market, it is tested many times for impurities and degradants, enantiomeric purity, and analytical and preparative isolations—it is tested during discovery and development and for under-regulated and unregulated methodologies. The book describes the use of SFC for each of these applications and discusses more in-depth topics, such as the use of SFC in mass spectrometric and polarographic detection. The book also sheds light on the role of SFC in drug development from natural products and the advancement of SFC with new technologies and its use in pilot-scale operations as a chromatographic technique.
