Table 4 Results of forced degradation studies
Degradation condition | Procedure | Observation | % degradant found |
|---|---|---|---|
Acid hydrolysis | 0.1 N Methanolic HCl reflux at 70 °C for 3 h | Degradant observed | 24.12 |
Base hydrolysis | 0.5 N Methanolic NaOH reflux at 70 °C for 5 h | Degradant observed | 9.75 |
Oxidative | 12% H2O2 at room temperature for 8 h | Degradant observed | 5.21 |
Thermal (dry heat and wet heat) | Solution kept in hot air oven at 80 °C for 8 h | No degradant observed | – |
Photolytic | Drug exposed to direct sunlight for 7 days | No degradant observed | – |