Research Article
Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib
Table 6
Standard run, run order, and response obtained for robustness testing.
| Standard | Run | Level | Resolution-1 (Bortezomib and Imp-C) | Resolution-2 (Imp-E and Imp-F) | % w/w | Factor A | Factor B | Factor C | | | Assay |
|
3
|
1
|
−1
|
1
|
1
|
3.0
|
2.3
|
99.3
|
1
|
2
|
1
|
1
|
−1
|
2.9
|
2.3
|
99.1
|
4
|
3
|
−1
|
−1
|
−1
|
3.1
|
2.4
|
99.3
|
5
|
4
|
0
|
0
|
0
|
3.5
|
2.6
|
99.9
|
6
|
5
|
0
|
0
|
0
|
3.4
|
2.5
|
100.1
|
2
|
6
|
1
|
−1
|
1
|
3.0
|
2.2
|
99.2
|
7
|
7
|
0
|
0
|
0
|
3.5
|
2.5
|
99.9
|
13
|
8
|
0
|
0
|
1
|
3.2
|
2.4
|
99.5
|
12
|
9
|
0
|
0
|
−1
|
3.4
|
2.3
|
99.6
|
15
|
10
|
0
|
0
|
0
|
3.4
|
2.6
|
99.8
|
14
|
11
|
0
|
0
|
0
|
3.5
|
2.5
|
99.9
|
16
|
12
|
0
|
0
|
0
|
3.5
|
2.6
|
100.1
|
8
|
13
|
−1
|
0
|
0
|
3.1
|
2.6
|
99.4
|
11
|
14
|
0
|
1
|
0
|
3.0
|
2.5
|
99.6
|
9
|
15
|
1
|
0
|
0
|
2.8
|
2.4
|
99.4
|
10
|
16
|
0
|
−1
|
0
|
3.2
|
2.5
|
99.8
|
|
|