Skip to main content

Table 6 Results for robustness study

From: Stability indicating RP-UPLC method for simultaneous quantification of bempedoic acid and ezetimibe in bulk and pharmaceutical formulations

Chromatographic changes

*Peak area

Tailing Factor

Theoretical Plates

*Assay (% w/w) ± SD, % RSD

  

BA

EZ

BA

EZ

BA

EZ

BA

EZ

Flow rate ± 0.1 (mL/min.)

0.4

45,118,072

12,608,841

1.184

1.407

3588

9450

100.59 ± 0.1799, 0.18

99.91 ± 0.3205, 0.32

 

0.5

44,965,324

12,588,406

1.172

1.166

3041

7911

  
 

0.6

45,051,231

12,583,731

1.144

1.123

2455

7299

  

Temperature ± 5 (°C)

20

45,036,493

12,584,203

1.155

1.163

3481

9827

100.51 ± 0.2184, 0.22

99.88 ± 0.4116, 0.41

 

25

44,906,494

12,580,784

1.181

1.173

3112

8067

  
 

30

45,086,495

12,612,046

1.108

1.122

2484

6857

  

Detection wavelength ± 2 (nm)

258

44,934,914

12,597,848

1.153

1.141

3585

9708

100.53 ± 0.1820, 0.18

99.60 ± 0.3573, 0.34

 

260

45,040,389

12,569,963

1.158

1.174

3088

8102

  
 

262

45,085,863

12,574,861

1.134

1.128

2548

6989

  
  1. *Mean of three determinations; SD = Standard Deviation; RSD = Relative Standard Deviation