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Table 6 Robustness and ruggedness studies of the developed method

From: Determination of flutamide and two major metabolites using HPLC–DAD and HPTLC methods

HPTLC method

Robustness (SD)a

Factor

Flu-1

Flutamide

Flu-3

1-Amount of acetic acid (± 0.01 mL/min)

0.03

0.03

0.03

2-% Tetrahydrofuran in the mobile phase (± 1%)

0.62

1.25

0.94

3-Detection wavelength (± 2 nm)

1.1

0.73

0.86

Ruggedness (SD)a

 1-Two analysts

0.009

0.004

0.009

HPLC method

Robustness (SD)a

Factor

Flutamide

Flu-1

Flu-3

1-Mobile phase flow rate (± 0.05 mL/min)

2.916

0.742

0.446

2-% acetonitrile in the mobile phase (± 1%)

2.423

2.604

2.964

3-Detection wavelength (± 2 nm)

0.456

0.582

0.516

Ruggedness (SD)a

 1-Two analysts

0.196

0.412

0.269

 2-Different acetonitrile manufacturer

0.939

1.33

0.287

  1. aAverage of 3 determinations