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Table 6 Robustness of ERTU and MET

From: Development and validation of stability-indicating RP-HPLC method for the simultaneous determination of ertugliflozin pidolate and metformin hydrochloride in bulk and tablets

Parameter

Modified condition

% RSD of peak area (NMT 2.0 %)

Theoretical plates* N (> 2000)

Tailing factor* (< 2.0)

Rs* (> 2.0)

ERTU

MET

ERTU

MET

ERTU

MET

Flow rate (ml/min)

0.9

0.893

1.209

12,959

10,911

1.17

1.17

7.96

1.0

0.531

0.382

11,679

9947

1.23

1.33

7.21

1.1

0.949

1.113

11,564

9463

1.21

1.16

7.63

ACN ratio in mobile phase

Buffer: ACN (% v/v)

70:30

1.377

1.039

11,949

11,751

1.26

1.15

9.2

65:35

0.531

0.382

11,679

9947

1.23

1.33

7.21

60:40

1.360

1.293

12,741

9485

1.22

1.14

6.78

Temperature (°C)

25

0.912

1.278

13,396

9470

1.14

1.20

7.03

30

0.531

0.382

11,679

9947

1.23

1.33

7.21

35

0.574

0.993

13,396

9516

1.21

1.17

7.01

  1. * All the values were expressed as mean of six determinations