Test |
Performance Criteria / Testing Method |
System Suitability |
Column efficiency of >1200
Five replicate injections RSDa ≤ 2.0%
Asymmetry < 1.5
Resolution >1.25
Capacity Factor (C1) between 2 and 7 |
Robustness |
±2.5% change in methanol composition in mobile phase, ±5°C change in derivatization temperature, ±10% change of mobile phase flow rate, different injection volume (10, 15, and 20 µl) |
Specificity |
No interfering peaks of the same retention time as either Gentamicin Sulfate or L-leucine with peak area above 1% of the corresponding lowest standard for both non stressed and acid stressed samples |
Linearity |
R2> 0.98 |
Accuracy/Recovery |
85 – 115% of Theoretical (80 – 120% at LOQb) |
Repeatability |
≤ 15% RSDa(≤ 20% RSDa at LOQb) |
Intermediate Precision |
≤ 15% RSDa(≤ 20% RSDa at LOQb) |
LOQb |
Tested at: Gentamicin Sulfate = 50 µg/mL
L-leucine = 0.5 µg/mL |
LODc |
Tested at: Gentamicin Sulfate = 5 µg/mL
L-leucine = 0.2 µg/mL |
aRelative Standard Deviation
bLimits of Quantification
c Limits of Detection |