TABLE 2.
Recovery of know impurities in selpercatinib.
| Substance | Target level | Spiked conc. (μg/mL) | Determined conc. (μg/mL) | Recovery (%) | Average recovery rate (%) | RSD (%) |
|---|---|---|---|---|---|---|
| imp-A | 50% | 0.511 | 0.508 | 99.41 | 99.53 | 2.42 |
| 0.511 | 0.528 | 103.33 | ||||
| 0.511 | 0.499 | 97.65 | ||||
| 100% | 1.021 | 1.052 | 103.04 | |||
| 1.021 | 0.992 | 97.16 | ||||
| 1.021 | 1.032 | 101.08 | ||||
| 150% | 1.532 | 1.516 | 98.96 | |||
| 1.532 | 1.492 | 97.39 | ||||
| 1.532 | 1.498 | 97.78 | ||||
| imp-B | 50% | 0.508 | 0.495 | 97.44 | 99.29 | 2.15 |
| 0.508 | 0.512 | 100.79 | ||||
| 0.508 | 0.499 | 98.23 | ||||
| 100% | 1.016 | 0.998 | 98.23 | |||
| 1.016 | 1.029 | 101.28 | ||||
| 1.016 | 0.986 | 97.05 | ||||
| 150% | 1.524 | 1.506 | 98.82 | |||
| 1.524 | 1.497 | 98.23 | ||||
| 1.524 | 1.578 | 103.54 | ||||
| imp-C | 50% | 0.506 | 0.495 | 97.83 | 97.40 | 1.84 |
| 0.506 | 0.487 | 96.25 | ||||
| 0.506 | 0.511 | 100.99 | ||||
| 100% | 1.012 | 0.995 | 98.32 | |||
| 1.012 | 0.975 | 96.34 | ||||
| 1.012 | 0.968 | 95.65 | ||||
| 150% | 1.518 | 1.455 | 95.85 | |||
| 1.518 | 1.462 | 96.31 | ||||
| 1.518 | 1.504 | 99.08 | ||||
| imp-D | 50% | 0.517 | 0.523 | 101.16 | 98.11 | 2.09 |
| 0.517 | 0.508 | 98.26 | ||||
| 0.517 | 0.493 | 95.36 | ||||
| 100% | 1.034 | 1.008 | 97.49 | |||
| 1.034 | 0.992 | 95.94 | ||||
| 1.034 | 1.026 | 99.23 | ||||
| 150% | 1.551 | 1.493 | 96.26 | |||
| 1.551 | 1.529 | 98.58 | ||||
| 1.551 | 1.562 | 100.71 |