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Journal of Chemistry
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2013
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Article
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Tab 6
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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.
Parameter
Variation
Resolution between solifenacin and impurity-C
Resolution between impurity-A and B
1
Temperature (±5°C of set temperature)
(a) At 33°C
3.8
8.7
(b) At 37°C
3.4
8.1
2
Flow rate (±20% of the set Flow)
(a) At 0.8 mL/min
3.9
8.9
(b) At 1.2 mL/min
3.5
8.3
3
pH (±0.2 units of set pH)
(a) At 3.3
3.1
8.8
(b) At 3.7
3.3
8.6