Table 3 Parameters evaluated for the validation of the analytical method used in quantifying affinin
Parameters | Results | Criteria of acceptancea |
|---|---|---|
System accuracy | CV = 1.2% | CV ≤ 1.5% |
System suitability | CV = 0.8%; K = 4.5; R = 3.2; T = 0.9; N = 6529 | CV ≤ 2%, K’ > 2; R > 2; T < 2; N > 2000 (each injection) |
System linearity | r2 = 0.99 IC(β1) = 128,382–14,1873 | r2 ≥ 0.98 IC(β1) must not include zero |
Accuracy and repeatability of the method | CV = 1.3% IC(μ) = 99.7–103.6% Recovery average = 101.6% | CV of the recovery percentage < 2% IC(μ) must include 100% or that the arithmetic average of the recovery percentage is included in the interval: 98–102% |
Method Linearity | r2 = 0.99 IC(β1) = 0.7–1.2 IC(β0) = -5.7–10.9 CVy/x = 1.4% | r2 > 0.98 IC(β1) must include the unit IC(β0) must include zero CVy/x of the recovery percentage < 2% |
Intermediate precision of the method | CV = 1.2% | CV ≤ 2% |
Detection and quantification limits | LD = 1.7 μg/mL LC = 5.3 μg/mL r2 = 0.99 IC(β1) = 17,7366–91,883 | r2 ≥ 0.98 IC(β1) must not include zero |