Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form

Table 2

Forced degradation study results.

Stress condition	Period of study	% assay of active substance	% of degradant
Undegraded	—	99.95	—
Acid hydrolysis (0.5 M HCl, at 60°C)	5 days	99.61	ND
Basic hydrolysis (0.5 M NaOH at 60°C)	5 days	99.98	ND
Oxidation (3% H2O2 at ambient temperature)	3 hrs	100.01	ND
Aqueous hydrolysis at 80°C	5 days	99.20	ND
Thermal degradation	5 days	99.63	ND
Photolytic degradation	11 days	99.96	ND

ND: not detected.