Factor Level Mean % assay(n=3), % RSD of results

Atorvastatin

Ezetimibe

Fenofibrate

Flow rate (mL/min)

0.8

100.6, 0.79

100.4, 0.49

100.2, 0.32

1.0

98.6,   0.40

98.6,   1.25

99.6,  0.83

Column oven temperature (°C)

45

99.1,   0.82

99.0,   0.51

99.5,  1.33

35

99.8,   1.53

100.6, 1.21

99.9,  1.18

Separation Column

Column  Ia

100.9,  0.69

99.6,   1.10

99.4,   0.58

Column  IIb

99.8,    1.53

101.2, 0.28

100.2, 1.16

Measurement wavelength (nm)

239

99.35,  1.53

99.6,   1.50

99.9,  0.76

241

99.91,  1.07

98.4,   0.48

99.8,  0.59

Table 3: Result of robustness study.