Research Article
In Vitro-In Vivo Correlation Evaluation of Generic Alfuzosin Modified Release Tablets
Table 3
Intraday precision and accuracy for QC samples, LLOQ, and ULOQ for alfuzosin in human plasma (EDTA).
| | Batch run | HQC | MQC | LQC | LLOQ | ULOQ | | (25 ng/mL) | (2 ng/mL) | (0.150 ng/mL) | (0.050 ng/mL) | (30 ng/mL) |
| | Mean |
25.94
|
2.111
|
0.1543
|
0.04632
|
31.36
| | SD () |
0.7114
|
0.06474
|
0.01073
|
0.001933
|
0.4354
| | Precision |
2.7
|
3.1
|
7
|
4.2
|
1.4
| | Accuracy (%) |
104
|
106
|
103
|
92.6
|
105
| | BIAS (%) |
3.8
|
5.6
|
2.9
| −7.4 |
4.5
| | n |
6
|
6
|
6
|
6
|
6
| | Overall mean |
25.88
|
2.069
|
0.1554
|
0.05092
|
30.97
| | SD () |
1.415
|
0.1162
|
0.009395
|
0.004951
|
1.578
| | Precision |
5.5
|
5.6
|
6
|
9.7
|
8.1
| | Accuracy (%) |
104
|
103
|
104
|
102
|
103
| | BIAS (%) |
3.5
|
3.5
|
3.6
|
3.8
|
3.2
| | n |
18
|
18
|
18
|
18
|
18
| | Recovery | Internal standards was 68% and analyte was 79% |
|
|
