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Table 4 Result from stress degradation study of AV

From: Comprehensive stability-indicating method development of Avanafil Phosphodiesterase type 5 inhibitor using advanced Quality-by-Design approach

Forced degradation condition Stress degradation condition Appropriate degradation observed % Mass balance obtained
Acid hydrolysis 1N HCl at 60 °C for 9 h 21.710 89
1N HCl at 70 °C for 8 h 25.620
1N HCl at 80 °C for 6 h 22.390
Alkaline hydrolysis 1N NaOH at 60 °C for 4 h 20.000 92
1N NaOH at 70 °C for 4 h 23.550
1N NaOH at 80 °C for 3 h 25.000
Neutral hydrolysis 60 °C for 12 h 14.001 91
70 °C for 12 h 16.902
80 °C for 12 h 19.210
Oxidative hydrolysis 1% H2O2 for 4 h 22.171 82
6% H2O2 for 2 h 30.521
10% H2O2 for 30 min 16.250
Photolytic degradation Solid state 8 h 22.391 98
Liquid state 6 h 23.000
Solid sample at 1.2 million lux h for 6 h in photostability chamber 28.966
Thermal degradation Solid state, 60 °C for 7 h 28.000 95
Liquid state, 60 °C for 5 h 28.501