Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Methods for Related Compounds and Assay of Solifenacin Succinate

Table 7

Summary of forced degradation results.

Stress condition	Time	%assay of active substance	Mass balance; (%assay + %impurities +; %degradation impurities)	Remarks
Acid hydrolysis (0.1N HCl)	4 hrs	100.7	100.8	No degradation is observed
Base hydrolysis (0.1N NaOH)	4 hrs	100.9	101.7	No degradation is observed
Oxidative (10% H2O2)	2 hrs	90.7	100.8	degraded into impurity-A and C and unknowns
Water hydrolysis	4 hrs	100.8	100.9	No degradation is observed
Thermal (80°C)	10 days	100	100.1	No degradation is observed
Light (Photolytic)	10 days	100.3	100.4	No degradation is observed