THE VALIDATION OF ANALYTICAL METHOD FOR RESIDUAL SOLVENTS (ACETONITRILE) IN RADIOPHARMACEUTICALS (18F-FDG) BY GC

Abstract

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-133 column 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.