Mass spectrometry in characterization of trace pharmaceutical components

The current regulatory quality standards require that pharmaceuticals in commerce are pure to the best possible extent, meaning that they are almost free from trace components, viz., impurities, degradation products, interaction products, etc. For almost one and a half decade, we have paid attention to the said trace components, with a single objective to provide assistance to generic industry in India. We established protocol in our laboratory for the purpose, essentially involving collection of liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-nuclear magnetic resonance (LC-NMR) data in a specific and systematic manner, and comparison of the same against data collected for the drug. We observed that most of the time data from hyphenated LC-MS tools alone were good enough to provide unequivocal structure characterization for drug-related trace components. The protocol, which is currently being employed universally for the purpose, has been successfully applied in our laboratories to 100 Industry sponsored projects involving characterization of synthetic impurities, and almost 50 publications on establishment of degradation chemistry of the generic drugs. (author)