The Analysis of Reference Standard Storage Failures Through the Use of Ibuprofen

Reference standards are commonly used in drug chemistry. They are used to calibrate the instruments and serve as a known point of reference for analysts’ ability to compare unknowns. Drugs can degrade over time or through environmental factors, causing contaminants to be present. In the event of environmental degradation while in storage, such as the exposure to high heat, it would be beneficial to have a database of known breakdown products in common drug reference standards for analysts’ reference. Using ibuprofen as an exemplar drug, this study attempted to identify the thermal breakdown products of ibuprofen and introduce the proposed database of breakdown products for different environmental degradations. To test the thermal degradation of ibuprofen, three tablets were incubated at 60 degrees Celsius for 10 consecutive days. There were three trials of this experiment, totaling nine degraded samples and one control. Each sample was run on the gas chromatograph/mass spectrometer and the Fourier transform infrared spectrometer. The GC/MS data showed that 78% of the degraded samples had identifiably different ions from the control, showing that degradation can be confirmed in GC/MS analysis. However, FTIR analysis showed that 67% of the degraded samples were largely similar to the control, so it was concluded that thermal degradation cannot be shown through FTIR analysis. The attempt at introducing a drug degradation database using this study was partially successful. More research and experimentation are needed on degradation pathways as well as the other main types of environmental degradation to form a complete database.