Thermogravimetry coupled to an atmospheric pressure photo ionization quadrupole mass spectrometry for the product control of pharmaceutical formulations and the analysis of plasticizers in polymers.

The development of a thermogravimetry coupled to an atmospheric pressure photoionization mass spectrometry (TG-APPI-MS) with a high temperature and flexible transfer line is presented. A method was developed to analyze plasticizers in solution which consist of a solvent evaporation step and subsequent evaporation of the analyte. These solutions of dibutyl phthalate (DBP) in hexane were used to investigate the repeatability (RSD: 3.6%) and linearity (R2: 0.9995) of the new developed system. With the new device the detection of different phthalates in a standardized PVC (polyvinyl chloride) polymer is shown. On the example of ASA, the degradation of a pharmaceutical drug is investigated. The dimerization and the possible trimerization of ASA during the thermal degradation is shown. Ten tablets of different ASA manufacturers were analyzed with the new developed analysis platform. The active substance was found in every tablet. Differences in mass spectral data as well as the studying of the pack insert were used to assign the tablets to companies and their subsidiaries. A unique formulation of ASA was found to have a different mass pattern when analyzed with TG-APPI-qMS. The developed device is a promising tool for the product control and the identification of falsified drugs.