| Parameter |
Bortezomib |
Imp-1 |
Imp-2 |
Imp-3 |
Imp-4 |
Imp-5 |
| |
| LOD (%) |
0.006 |
0.010 |
0.009 |
0.010 |
0.009 |
0.009 |
| LOQ (%) |
0.02 |
0.03 |
0.03 |
0.03 |
0.03 |
0.03 |
| Slope (m) |
128913 |
154578 |
136181 |
76737 |
90394 |
108964 |
| Intercept (C) |
84.91 |
-84.978 |
-24.5868 |
-109.83 |
89.05988 |
-24.9701 |
| Correlation coefficient |
0.99976 |
0.9993 |
0.99988 |
0.99995 |
0.99960 |
0.99982 |
| Precision (%RSD)a |
2.9 |
4.0 |
2.5 |
3.6 |
4.6 |
3.7 |
Linearity range was LOQ-150% w.r.t 2.0 mg/ml bortezomib for impurities; Linearity range was 50-150% of bortezomib.
aSix determinations using LOQ solutions for impurities and bortezomib. |
