This study presents a method for comparison of related impurities in a brand and a generic over-the-counter (OTC) acetaminophen drug. The workflow comprised an Agilent InfinityLab liquid chromatography/mass selective detector (LC/MSD iQ) and an Agilent 1290 Infinity II LC. The study identified impurities at concentrations lower than can be reliably detected by UV.
Most OTC pharmaceutical drugs are available as a generic form developed from a brand name product, and do not require a prescription for purchase. These generic products are sold by different manufacturers to help spur competition, and potentially lower prices making the drug more affordable. Generic OTC drugs manufacturers must meet the same quality attributes such as strength, purity, stability, and the limits for related impurities as determined by the USFDA for approved brand name drugs.1 Generic drug manufacturers must be able to characterize their product and its impurities, typically with HPLC and UV detection. Adding a mass selective detector can significantly reduce the analysis time of typical USP or EP methods2 since coeluting components can be unambiguously determined by the mass of target compounds.
This study shows the comparison of related impurities in a brand versus generic OTC drug of acetaminophen. Impurities were screened using an InfinityLab LC/MSD iQ and, 1290 Infinity II LC. The LC/MSD iQ, based on single quadrupole technology, is a robust detection system designed to be easy to use and reliable. It is an intuitive instrument that requires minimal user training. It can handle high LC flow rates, and automatically optimizes MS parameters to provide optimal results. The use of mass determination ensures unambiguous detection of active pharmaceutical ingredients (APIs), their related impurities, and, more importantly, any unknown or unexpected impurities. Chromatographers can easily incorporate the LC/MSD iQ as a new module in their existing LC stack. It is specifically designed to be easily integrated into the Agilent 1260 Infinity II LC, 1290 Infinity II LC, or even older LCs with a space-design that plugs into the same power outlets as the LC modules. The HPLC stack, including the MS and vacuum pump, can be stored on the Agilent InfinityLab Flex Bench MS, freeing bench space, and allowing the entire system to be relocated swiftly and safely.
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