Name
Limit of detection (%w/w)
Limit of quantitation (%w/w)
Retention time (minutes)
Relative retention time
Relative response factor
Co-relation coefficient (R
2
)
DAB Impurity-A
0.01
0.03
2.88
0.09
1.30
1.0000
DAB-2B
0.01
0.03
10.34
0.34
0.91
0.9962
DAB Impurity-C
0.01
0.03
14.83
0.48
0.93
1.0000
DAB Impurity-H
0.01
0.03
15.84
0.52
1.42
1.0000
DAB Impurity-D
0.01
0.03
16.53
0.54
0.93
0.9999
DAB Impurity-E
0.01
0.03
22.20
0.73
0.95
1.0000
DAB Impurity-K
0.01
0.03
25.91
0.85
0.96
0.9979
DAB Impurity-J
0.01
0.03
26.97
0.88
0.86
0.9958
DabigatranEtexilateMesylate
0.01
0.03
30.62
1.00
1.0
0.9832
DAB Impurity-G
0.01
0.03
36.97
1.21
1.70
0.9895
Table 6:
Result of Linearity and relative response factor for all impurities
