Table 2

Test	Performance Criteria / Testing Method
System Suitability	Column efficiency of >1200 Five replicate injections RSD^a ≤ 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 LOQ^b)
Repeatability	≤ 15% RSD^a(≤ 20% RSD^a at LOQ^b)
Intermediate Precision	≤ 15% RSD^a(≤ 20% RSD^a at LOQ^b)
LOQ^b	Tested at: Gentamicin Sulfate = 50 µg/mL L-leucine = 0.5 µg/mL
LOD^c	Tested at: Gentamicin Sulfate = 5 µg/mL L-leucine = 0.2 µg/mL
^aRelative Standard Deviation ^bLimits of Quantification ^c Limits of Detection

Table 2: Analytical qualification performance criteria for the determination of Gentamicin Sulfate and L-leucine in formulations.