​The validation of the analytical method of residual solvent by gas chromatography (GC) provides objective evidence that is suitable for its intended purpose. Acetonitrile residual solvent can be found in 18F-FDG radiopharmaceuticals (less than 0.41mg/mL). This study aims to research and validate the analytical method for the determination of residual solvents (Acetonitrile) in 18F-FDG radiopharmaceuticals. The Agilent GC7890B Gas Chromatograph which contains a flame ionization detector (FID), HP-INNOWAX 19091N-133column and autosampler were used in this research. Validation characteristics are based on the Guidelines of the Ministry of Health; The specificity showed good results (retention time of sample and standard ACN is 3.809 min). The system suitability test showed good results (RSD of retention time is 0.019% and RSD of peak area is 4.269%). The linearity was investigated at five concentration levels in a range between 0.2 and 0.6mg/mL concentrations and obtained the linear regression equation y = 315,94871x - 1,21442 with the correlation coefficient r = 0.998. The method has repeatability (RSD of peak area is 1.37%). Intermediate precision (RSD between 2 analysts is 2.62%). The limit of detection (LOD) is 0.0019mg/mL, the limit of quantification (LOQ) is 0.0063mg/mL. This method is applied to determine ACN residual solvent in 18F-FDG radiopharmaceuticals produced at Hanoi Irradiation Center.

Keywords: Validation of analytical method, 18F-FDG, GC7890B, Acetonitrile.