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Table 7 Method validation results of Bempedoic acid and Ezetimibe by UPLC

From: Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method

Parameter

Bempedoic acid

Ezetimibe

Concentration (µg/ml)

Result

Concentration (µg/ml)

Result

Linearity

18–360

CC: 0.999

1–20

CC: 0.999

Accuracy

90

% Rec: 100.1

5

%Rec: 99.5

180

%Rec: 99.9

10

% Rec: 99.3

270

% Rec: 99.6

15

% Rec: 99.9

Intraday precision

180

%RSD: 0.87

10

%RSD: 0.65

Interday precision

180

%RSD: 0.36

10

%RSD: 0.61

Robustness

    

Flow Plus

Flow Minus

180

180

0.41

0.37

10

10

0.33

0.82

Organic Plus

180

0.78

10

0.51

Organic Minus

180

0.52

10

0.78

Wavelength Plus

180

0.42

10

0.84

Wavelength Minus

180

0.39

10

0.92

  1. CC correlation coefficient
  2. % REC-% Recovery
  3. %RSD: Relative standard deviation