DOI: 10.1002/9781118271858.ch8 In book: Analytical Techniques for Clinical Chemistry, Edition: New York, Chapter: The Role of Analytical Chemistry in the Safety of Drug Therapy, Publisher: Wiley-Blackwell, Editors: S. Caroli, Gy. Záray, pp.175-239
This chapter contains sections titled: SummaryDrug Quality and Analysis: Their Role in Drug SafetyMethodological AspectsThe Role of Analytical Chemistry in Drug Research, Development, and ProductionFuture TrendsReferences
[Show abstract][Hide abstract] ABSTRACT: We review and discuss recent developments and the main trends in the determination of volatile impurities in drugs, with literature references and applications. We present an overview of regulatory and pharmacopeial status and trends. The techniques described are direct injection, static headspace and solid-phase microextraction (SPME) gas chromatography (GC) together with some gravimetric and thermogravimetric applications. Relevant research provided solutions to all the main challenges in static headspace GC techniques. SPME was extensively used, mainly for identification purposes.
[Show abstract][Hide abstract] ABSTRACT: For a considerable time, thin-layer chromatography (TLC), or planar chromatography (PC), was called the “Cinderella” or the “Princess” of chromatographic techniques. This expression was chosen to characterize the ability of this versatile method to be renewed and “reinvented” over and over again. Unfortunately, today, only classical, semi-quantitative TLC procedures can be found in the various (and conservative) pharmacopoeias. In addition, the number of TLC applications is steadily decreasing, being replaced by HPLC methods that are considered more appropriate. The newest developments in instrumental TLC are more or less neglected by the pharmacopoeias, but can nevertheless be used by analysts in both research and quality control as it is a fast, relatively low-cost technique. This article surveys recent developments in instrumentation of TLC and some examples of applications from different fields of pharmaceutical analysis, and expresses hope for the future of this method.
[Show abstract][Hide abstract] ABSTRACT: Advances in HPLC technology have improved capability for drug impurity profiling in terms of faster analysis time, better separations and faster method development. We review developments in monolithic columns, sub-2-μm particle columns operated at typical or high pressures, high temperature operation, new stationary phases, systematic method development, column classification techniques and selected detectors.
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