Forced Degradation Study and Development of a Stability-Indicating Method for Amoxicillin Capsules According to ANVISA Guidelines

This study aimed to develop a reliable stability-indicating method (SIM) for amoxicillin 500 mg capsules (DP-drug product). A literature review addressing (AMX; DS-drug substance) forced degradation studies and the existing SIMs was conducted verify most significant outcomes. Subsequently, of DP DS carried out following Brazilian Health Surveillance Agency (ANVISA) guidelines, including thermal (dry wet heat), acidic alkaline hydrolyses, hydrogen peroxide oxidation, reaction with copper, photodegradation. Both were more susceptible 0.015 M NaOH, resulting in approximately 50% degradation. AMX not significantly photodegraded, but some products (PDegs) showed susceptibility light exposure. Thermodegraded samples showing ≥ 10% exhibited modified profiles thermogravimetric (TG) differential scanning calorimetric (DSC) analyses. The X-ray powder diffraction patterns (XRPD) exposed dry heat displayed complete amorphization AMX, attesting occurrence physical concomitantly chemical degradation, which can alter drug’s bioavailability. In contrast, thermodegraded intact crystals interspersed amorphous form, perhaps partly protected by excipient. validated SIM able detect quantify about 80 PDegs.