Parameters | Results (MCPA) | Acceptance limit | ||
---|---|---|---|---|
Linearity | Correlation Coefficient = 0.998 | Correlation Coefficient NLT 0.97 | ||
Precision | 0.11% RSD | % RSD NMT 2.0 | ||
Trueness | Conc. (mg/L) | % Recovered | % Recovery within 80–120% | |
150 | 99.3% | |||
200 | 99.4% | |||
250 | 99.5% | |||
300 | 99.3% | |||
350 | 99.3% | |||
Repeatability | (with respect to Instrument and Analyst) | 0.36% RSD | ||
Reproducibility | (with respect to Instrument) | HPLC–20AT | HPLC–10AT | RSD ≤ 2.0% |
0.36% RSD | 0.20% RSD | |||
[with respect to various Labs (ILC)] | Average | 0.16% RSD | ||
Detection and quantitation limit | LOD | LOQ | – | |
1.08 mg/L | 3.62 mg/L | |||
Robustness | Change | % RSD | % RSD NMT 1.5 | |
Flow rate = 1.3 mL | 0.20% | |||
Flow rate = 1.5 mL | 0.36% | |||
Flow rate = 1.7 mL | 0.05% | |||
(Mobile Phase) Methanol: Water 950: 50 | 0.24% | |||
(Mobile Phase) Methanol: Water 900: 100 | 0.36% | |||
(Mobile Phase) Methanol: Water 850: 150 | 0.20% |