New methods for the examination of poor quality medicines
Hostetler, Dana M.
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The production and distribution of counterfeit drugs is a critical health problem that plagues nations worldwide. The presence of counterfeit antimalarials has become especially worrying, as these drugs are most often needed by those living in nations whose resources to verify the medicine supply are lacking. Rapid analysis methods used for screening large quantities of poor quality antimalarials are critical in the battle to protect those in less developed regions of the world. Simple, cost effective analysis methods that can be used in the field must be developed so those whose governments cannot afford to maintain medicine regulatory agencies can still have faith in their medicinal supply. A very powerful screening method, Direct Analysis in Real Time Mass Spectrometry (DART-MS) has been used to investigate thousands of poor quality medicines. This method, however, is known to fragment molecules more readily than commonly used, 'softer' ionization methods, such as electrospray ionization. Excess fragmentation in 'harder' ionization sources is due to deposition of additional internal energy to the ionized molecules. This internal energy deposition can be measured, so the analyst can be knowledgeable as to what to expect when examining unknowns using this recently developed ionization source. Quantitation of the active pharmaceutical ingredient (API) in pharmaceuticals is crucial to the determination of what class a poor quality medicine fits into. Because poor quality drugs can be of different types, it is important to accurately classify them, in hopes of improving the supply of medicines available to those in less developed regions of the world. High performance liquid chromatography (HPLC) is most commonly used to quantify the active pharmaceutical ingredient in poor quality medicines, however, this method is time consuming, preventing its use in high throughput settings. During the course of my research, hundreds of poor quality pharmaceuticals were analyzed using DART-MS. The active pharmaceutical ingredient was detected during the rapid screening for many of these drugs, however, a more in depth analysis would often reveal less than the expected quantity of active ingredient. A rapid non-chromatographic quantitation method was developed using a mass spectrometer as the detector. This method allows for both quantitative and qualitative information regarding a specific sample to be obtained simultaneously, saving the analyst time and resources. Utilizing this non- chromatographic mass spectrometric method, degradation products have been identified, thus increasing our ability to classify drugs into their respective divisions.