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

Journal of Analytical Science and Technology

Table 4 Result from stress degradation study of AV

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
Thermal degradation	Liquid state, 60 °C for 5 h	28.501	95