Research Article

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

Table 6

Summary of robustness results.

S. No.ParameterVariationResolution between solifenacin and impurity-CResolution between impurity-A and B

1Temperature (±5°C of set temperature)(a) At 33°C3.88.7
(b) At 37°C3.48.1

2Flow rate (±20% of the set Flow)(a) At 0.8 mL/min3.98.9
(b) At 1.2 mL/min3.58.3

3pH (±0.2 units of set pH)(a) At 3.33.18.8
(b) At 3.73.38.6