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Table 4 Stability of EMPA in human plasma

From: A UPLC/DAD method for simultaneous determination of empagliflozin and three related substances in spiked human plasma

Parameters

Concentration (ng/mL)

%Recovery

%RSD

%RE

Short term

At 25 °C, 24 h

50 (LLOQ)

95.37

13.5

− 4.63

100 (LQC)

104.1

10.9

4.10

300 (MQC)

93.71

9.62

− 6.29

500 (HQC)

101.5

8.07

1.50

700 (ULOQ)

99.01

4.39

− 0.99

Long term

At − 20 °C, 30 days

50 (LLOQ)

90.63

11.2

− 9.37

100 (LQC)

93.82

7.37

− 6.18

300 (MQC)

95.13

5.97

− 4.87

500 (HQC)

103.7

7.11

3.68

700 (ULOQ)

108.4

8.94

8.42

Three freeze–thaw cycles thawed at 25 °C for 2 h, refrozen 24 h

50 (LLOQ)

92.07

12.9

− 7.93

100 (LQC)

101.7

8.66

1.70

300 (MQC)

91.91

10.1

− 8.09

500 (HQC)

93.44

9.79

− 6.56

700 (ULOQ)

97.12

4.64

− 2.88