Table 3.

Summary of validation parameters.

Validation Parameters	Result	Validation Acceptance criteria
Linearity (Range) (R2)	(10–40 μg /mL) (R2 = 0.998)	The coefficient of determination, R2, must be NLT 0.995 for Category I assays
Limit of Detection (LOD) μg/mL	3.091 µg/mL	The smallest measure of analyte that can be detected with reasonable certainty for a given analytical procedure
Limit of Quantitation (LOQ) (Mean Conc μg/mL) (%RSD)* LOQ Measurements with Respect to The Theoretical Concentration Of (10 μg/mL). *For Ten Replicates, N = 10	(9.982 μg/mL), (0.264%)	The measured concentration must be accurate and precise at a level ≤ 50%
Accuracy (Mean % Recovery)	102.17%	95.0%–105.0% mean recovery for the drug product assay
Repeatability (Intra-Day Precision) (%RSD)	(1.65%)	The relative standard deviation is NMT 2.0% for the drug product assay.