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Table 16 Result of robustness

From: Development and validation of RP-HPLC method for estimation of brexpiprazole in its bulk and tablet dosage form using Quality by Design approach

Sr.no.

Parameter

Observations

Limit

Changes in flow rate

Change in wavelength

Change in column oven temperature

1.2

0.8

219

213

32° C

28° C

1

Peak area response

13,429,477

20,188,069

1,589,0163

19,777,590

16,118,641

16,127,528

 

2

Theoretical plates

3681

3639

3678

3667

3672

3653

NMT 2000

3

Tailing factor

1.34

1.34

1.33

1.34

1.33

1.34

NMT 2.0

4

R.T. (min)

3.54

5.32

4.24

4.23

4.23

4.23