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Abstract

A REVIEW: ANALYTICAL METHODS FOR IMPURITY PROFILING

Kavinila S., Sathriyan M., Hardha B.* and Senthil Kumar M.

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Abstract

Impurity is any substance that exists alongside the original drug, such as starting material or intermediates, or that is generated as a result of any side reactions. An impurity profile is a description of the known and unknown contaminants found in pharmaceutical products. In the identification of small components (drugs, contaminants, degradation products, metabolites) in various matrices, very complex instrumentation, such as mass spectra meters linked to a Gas Chromatography or HPLC, is an unavoidable tool. The current page discusses the many impurities found in APIs, techniques for recognizing them, and potential solutions to cope with interferences produced by them in pharmaceutical analysis. Analytical procedures range from simple weighing to complex approaches requiring highly specialized apparatus. This study provides a brief introduction to process and product-related impurities, with an emphasis on the development of novel analytical methods for their detection. It describes the use of current analytical techniques, particularly ultra-performance liquid chromatography (UPLC), liquid chromatography-mass spectrometry (LC-MS), high-resolution mass spectrometry (HRMS), gas chromatographymass spectrometry (GC-MS), and high-performance thin layer chromatography (HPTLC). In addition, the use of nuclear magnetic resonance (NMR) spectroscopy for the characterization of impurities and degradation products was discussed.

Keywords: Impurity, analytical techniques, isolation, characterization.


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