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Table 1 Robustness data

From: Development of novel gradient RP-HPLC method for separation of dapagliflozin and its process-related impurities: insight into stability profile and degradation pathway, identification of degradants using LCMS

Parameter

Resolution b/w DFP and 5-BC impurity

Flow rate 1.0 ml/min (actual)

3.4

Flow rate 0.9 ml/min, (low flow)

3.8

Flow rate 1.1 ml/min, (high flow)

3.3

Wavelength 210 nm (actual)

3.4

Decreased wave length 208 nm

3.8

Increased wave length 212 nm

3.7

Temp minus (28 °C)

3.7

Temp plus (32 °C)

3.8

Temp optimum (30 °C)

3.6