Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib
Table 4
Regression data.
Parameter
Bortezomib
Imp-A
Imp-B
Imp-C
Imp-D
Imp-E
Imp-F
Imp-G
Imp-H
Imp-I
LOD (μg/mL)
0.043
0.012
0.025
0.043
0.043
0.047
0.038
0.045
0.024
0.060
LOQ (μg/mL)
0.174
0.048
0.100
0.173
0.174
0.188
0.152
0.179
0.097
0.239
Regression equation (y) Slope (b)
13289
22831
20852
12009
13934
14688
19330
17640
15812
8765
Intercept (a)
−404
−309
−296
130
45
−386
344
−486
−397
617
Correlation coefficient
0.9995
0.9995
0.9998
0.9993
0.9995
0.9993
0.9994
0.9997
0.9998
0.9996
Linearity range is LOQ-150% with respect to 1.0 mg/mL of bortezomib for impurities; Linearity range is 50–150% with respect to 1.0 mg/mL of bortezomib for assay.
