Instrumental Methods in Analysis of Drug Impurities

Establishing the impurity profile of an active substance or final pharmaceutical product requires use of several analytical methods to fully and precisely identify all of the impurities. 

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Methods in the analysis of drug impurities (e.g., ultraviolet, UV Fourier transform infrared, FT-IR nuclear magnetic resonance, NMR mass spectrometry, MS) are used to separate, identify, and quantify impurities, as well as establish their structure. Currently the most efficient methods seem to be combined techniques such as GC-MS, LC-MS, liquid chromatography-diode-array detection-mass spectrometry (LC-DAD-MS), LC-NMR, LC-DAD-NMR-MS, etc. [18-20]. 

Based on collective studies [18-20] and review publications [21-24], we present the most useful instrumental methods used in the analysis of drug impurities. 

The first stage of impurity analysis is to separate the impurities from the active substance and excipients. For this, the following methods are used  

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