Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib
Table 5
Accuracy study.
Added % ()
Assay
Related substances determination
Added (in ppm)
% Recovery
% RSD
Added (in ppm)
Imp-A
Imp-B
Imp-C
Imp-D
Imp-E
Imp-F
Imp-G
Imp-H
Imp-I
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
Recovery (%)
RSD (%)
50
500
99.8
0.4
0.75
105.5
1.5
104.8
2.9
104.7
3.1
105.2
2.0
96.5
2.5
102.2
2.2
103.3
1.3
99.7
0.5
99.5
2.5
100
1000
99.6
0.4
1.50
104.8
2.5
102.6
1.1
104.1
1.4
106.4
2.7
105.2
2.2
101.5
1.4
101.4
2.6
97.9
1.1
108.3
2.9
150
1500
99.9
0.3
2.25
106.7
1.2
102.5
1.1
107.4
2.1
94.2
2.3
101.1
0.6
97.3
0.7
101.8
2.3
103.1
0.8
99.8
1.6
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