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Table 6 Robustness study

From: Development and validation of stability-indicating RP-HPLC method for the simultaneous estimation of xylometazoline hydrochloride and ipratropium bromide from nasal spray dosage form

Sr. no.

 

Xylometazoline

Ipratropium bromide

Xylometazoline

Ipratropium bromide

  

Decrease in flow rate (0.9 mL/min)

Increase in flow rate (1.1 mL/min)

1

% RSD of six standard inj.

0.85%

0.47%

0.33

0.36

 

Tailing factor

1.5

1.5

1.6

1.5

 

Theoretical plates

47107

8743

48581

8230

 

Change in column oven temperature ±5 °C of 45 °C

2

 

Decreases in column temperature (40 °C)

Increases in column temperature (50 °C)

 

% RSD of six standard inj.

0.48

0.28

0.29

0.24

 

Tailing factor

1.6

1.5

1.6

1.5

 

Theoretical plates

50569

6784

40259

6510

 

Change in wavelength ± 3 nm of 210.0 nm

3

 

Decrease in wavelength (207.0 nm)

Increase in wavelength (213.0 nm)

 

% RSD of six standard inj.

0.08

0.20

0.06

0.28

 

Tailing factor

1.4

1.6

1.4

1.6

 

Theoretical plates

50027

5214

50891

5323