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.

StandardRunLevelResolution-1
(Bortezomib and Imp-C)
Resolution-2
(Imp-E and Imp-F)
% w/w
Factor AFactor BFactor CAssay

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