Parameter | Results | ICH limits | |
---|---|---|---|
MET | ERTU | ||
Retention time (min) | 2.170 | 2.929 | - |
System suitability parameters | |||
% RSD | 0.382 | 0.531 | NLT 2.0 |
Theoretical plates | 9947 | 11679 | MT 2000 |
Tailing factor | 1.25 | 1.23 | NMT 2.0 |
Range (μg/ml) | 62.5–375 | 0.9375–5.625 | - |
Linearity (R2) | 0.999 | 0.999 | NLT 0.999 |
% Recovery | 99.11–101.13 | 99.27–100.60 | 98–102 |
% RSD | |||
Intra-day precision | 0.42 | 0.25 | NMT 1.0 |
Inter-day precision | 0.56 | 0.70 | NMT 2.0 |
LOD (μg/ml) | 0.87 | 0.025 | - |
LOQ (μg/ml) | 2.63 | 0.076 | - |
% Assay difference at 24 h | 1.51 | 1.74 | NMT 2.0 |
% Assay | 99.48 | 99.31 | - |