| Parameter |
Impurity-A |
Impurity-B |
Impurity-C |
Impurity-D |
Impurity-E |
Impurity-F |
| System suitability |
| RT |
17.375 |
12.714 |
10.539 |
31.270 |
18.380 |
20.544 |
| RRT |
3.174 |
2.323 |
1.920 |
5.713 |
3.358 |
3.753 |
| Linearity (r2) |
0.99876 |
0.99966 |
0.99937 |
0.99900 |
0.99969 |
0.99814 |
| Quantitation |
| Limit (%) |
0.013 |
0.008 |
0.012 |
0.009 |
0.003 |
0.0011 |
| Detection |
| Limit (%) |
0.003 |
0.002 |
0.003 |
0.0022 |
0.0007 |
0.0002 |
| Precision at |
| QL (RSD) |
0.74 |
2.39 |
2.26 |
4.21 |
1.47 |
3.43 |
| % Recovery at |
| QL (n=3) |
100.12 |
101.45 |
99.02 |
104.55 |
100.73 |
98.09 |
| Accuracy (% Recovery) |
| 50% |
100.61 |
99.11 |
103.14 |
98.62 |
101.05 |
97.86 |
| 75% |
102.14 |
99.31 |
99.39 |
99.59 |
94.23 |
98.29 |
| 100% |
97.25 |
100.18 |
99.90 |
98.48 |
101.23 |
103.42 |
| 125% |
92.72 |
99.28 |
98.20 |
98.49 |
101.60 |
106.90 |
| 150% |
100.66 |
98.44 |
98.83 |
99.68 |
98.44 |
105.80
|
Note: n, number of determinations; RT, retention time; RRT, relative retention time;
R2, correlation coefficient. Table 1 shows different parameters of validation along
with their respective results. It includes system suitability, linearity, quantitation
limit, detection limit, precision at QL, and accuracy (with various concentrations
such as 50%, 75%, 100%, 125%, 150%). |
