Table 5. Method Comparison Analysis Data with USP Method (F and T-test).
| Results (Recovery (%), Precision (%RSD) | |||
|---|---|---|---|
| Test | Parameter | Acceptance Criteria | CMN |
| USP Method | n = 6 (6 determinations at 100% specification level) | Recovery at each level should be 98–102% | 99.3 |
| 100.2 | |||
| 99.4 | |||
| 100.2 | |||
| 99.6 | |||
| 100.1 | |||
| Mean | 99.8 | ||
| RSD | 0.4 | ||
| Current Method | n = 6 (6 determinations at 100% specification level) | Recovery at each level should be 98–102% | 100.9 |
| 100.2 | |||
| 100.9 | |||
| 99.6 | |||
| 98.9 | |||
| 100.6 | |||
| Mean | 100.2 | ||
| RSD | 0.8 | ||
| F-test | Degrees of freedom | 5 | |
| F-Value | 0.8595 | ||
| P-Value | 0.4361 | ||
| F-Critical One tail | F < F criticala | 5.0503 | |
| T-Test | Degrees of freedom | 5 | |
| T-Value | –0.9363 | ||
| P-Value One tail | 0.196 | ||
| T-Critical One tail | T < T criticala | 2.015 | |
| P-Value Two tail | 0.3921 | ||
| T-Critical Two tail | T < T criticala | 2.5706 |
Indicates reject null hypothesis, i.e., no statistical significance (differences) observed between the current and USP method.