Table 1.
UHPSFC‐DAD assay method validation results
| 1 | 2 | 3 | 5 | 6 | 7 | 8 | |
|---|---|---|---|---|---|---|---|
| Reg. equi. | y = 620.9x–2536.1 | y = 677.7x–4208.4 | y = 374.4x–1027.8 | y = 856.0x–1071.2 | y = 511.5x–835.46 | y = 588.0x–6864.2 | y = 464.6x + 866.24 |
| R 2 | 0.9998 | 0.9994 | 0.9997 | 0.9999 | 0.9996 | 0.9991 | 0.9987 |
| Linearitya | 6.4–1030.0 | 6.4–1075.0 | 6.5–921.0 | 5.4–869.0 | 5.8–897.3 | 9.5–953.4 | 6.6–1035.0 |
| LODb | 1.0 | 0.8 | 1.3 | 1.1 | 0.8 | 1.6 | 2.0 |
| LOQb | 3.0 | 2.5 | 3.8 | 3.3 | 2.3 | 4.9 | 6.0 |
| Precision | |||||||
| Intra‐dayc | 1.6 | 1.2 | 1.7 | 1.6 | 2.1 | 1.8 | 1.4 |
| Inter‐dayd | 1.4 | 1.1 | 2.6 | 2.1 | 2.1 | 2.2 | 1.9 |
| Accuracye | |||||||
| Low | 100.2 ± 0.9 | 100.2 ± 2.8 | − | 101.7 ± 4.7 | 107.2 ± 2.6 | 96.9 ± 4.7 | – |
| Medium | 102.0 ± 2.0 | 100.7 ± 4.1 | − | 98.7 ± 2.5 | 105.3 ± 1.8 | 97.3 ± 1.9 | – |
| High | 102.5 ± 2.5 | 99.2 ± 1.9 | − | 98.1 ± 1.6 | 106.5 ± 2.3 | 104.2 ± 3.1 | – |
a
Linearity range from LLOQ to ULOQ in µg/mL
b
µg/mL
c
Maximum deviation within one day based on peak area in percent (n = 3 on each day)
d
Deviation within three days based on peak area in percent (n = 9)
e
Recovery values (n = 3) in percent (mean ± RSD)