Table 5 Method validation summary for HPLC and GC method

 Specificity

The method is specific for [¹⁸F]AlF-NOTA-octreotide, NOTA-octreotide, metal complexes of NOTA-octreotide and octreotide (resolution ≥1.5)

 Linearity

The method is linear in the tested range

Range 2.01–29.92 μg/mL, R² > 0.995 for NOTA-octreotide

 Method precision

6 repeated injections of 20 μL of a 5.026 μg/mL NOTA-octreotide solution yield a % RSD AUC of 3.5% and a % RSD of retention time of 0.2%.

 Quantification and detection limits of NOTA-octreotide, AlF-NOTA-octreotide and metal complexes of NOTA-octreotide^a

LOD = 0.30 μg/mL

LOQ = 1.0 μg/mL

 Recovery [¹⁸F]F⁻, [¹⁸F] AlF and [¹⁸F]AlF-NOTA-octreotide

99.0 ± 1.4%, 100.1 ± 1.1% and 101.9 ± 1.8%

 Specificity

The method is specific for EtOH

 Linearity

R² > 0.99 for all tested solvents, range: 0.005% to 5% for CH₃CN and DMSO; 0.005% to 10% for EtOH

 Method precision

The % RSD of the AUC was < 5% and the %RSD of the retention time was < 1% for all tested solvents.

 Quantification and detection limits

LOD EtOH: 0.0006%; LOQ EtOH: 0.0020%