Stability Indicating Assay Method and LC-MS Characterization of Forced Degradation Products of Pantoprazole and Aspirin.

To assess the degradation of the drug under forced degradation, stability experiments with aspirin and pantoprazole were performed. Under the guidelines set forth by the International Conference on Harmonization, pantoprazole and aspirin were exposed to oxidation, alkaline and acidic hydrolysis and thermal stress. Under basic and acidic hydrolysis stress, the drug combination demonstrated significant degradation. Under conditions of oxidative stress and heat, however, it remained stable. A mobile phase, containing methanol: ammonium acetate buffer (0.01 M) (70: 30% v/v) was employed, a column (250 mm × 4.6 mm, and 5 μm), detection wavelength was 254 nm, flow rate of 0.8 mL min-1 was used. The degradation products were identified using LC-MS, and fragmentation paths were suggested. (Graphical abstract: Figure 1).