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Table 3 Results of method validation

From: Multivariate optimization of liquid chromatographic conditions for determination of dapagliflozin and saxagliptin, application to an in vitro dissolution and stability studies

Parameter

Dapagliflozin

Saxagliptin

Precision

Repeatability

Peak area

SD

% RSD

Peak area

SD

% RSD

 Intra-day

1989124

21017

1.05

3584561

21476

0.599

 Inter-day

2018092

23326

1.15

3551248

26363

0.742

Accuracy

Recovery level

Amount Spiked (μg/mL)

% Recovery

% RSD

Amount Spiked (μg/mL)

% Recovery

% RSD

 80%

80

100.3

0.16

40

100.6

0.39

 100%

100

100.2

0.10

50

100.9

0.40

 120%

120

100.1

0.10

60

100.3

0.57

System suitability

 Retention time

3.5

5.0

 Peak area

515956

602550

 Tailing factor

1.3

1.2

 Theoretical plates

6822

9773

 Capacity factor (K’)

2.5

4.0

 Selectivity factor (α)

1.6

 Resolution

7.3

  1. SD standard deviation, RSD relative standard deviation (n=6)