OBJECTIVE: In this presented work, an analytical method by gas chromatography coupled with flame ionization detection (GC-FID) has been developed to determine organic solvents in radiopharmaceutical samples. The effect of injection holding time, temperature variation in the injection port, and the column temperature on the analysis time and resolution (R ≥ 1.5) of ethanol and acetonitrile was studied extensively.
METHODS: The experimental conditions were optimized with the aid of further statistical analysis; thence, the proposed method was validated following the International Council for Harmonisation (ICH) Q2 (R1) guideline.
RESULTS: The proposed analytical method surpassed the acceptance criteria including the linearity > 0.990 (correlation coefficient of R2), precision < 2%, LOD, and LOQ, accuracy > 90% for all solvents. The separation between ethanol and acetonitrile was acceptable with a resolution R > 1.5. Further statistical analysis of Oneway ANOVA revealed that the increment in injection holding time and variation of temperature at the injection port did not significantly affect the analysis time. Nevertheless, the variation in injection port temperature substantially influenced the resolution of ethanol and acetonitrile peaks (p < 0.05).
CONCLUSION: The proposed analytical method has been successfully implemented to determine the organic solvent in the [18F]fluoro-ethyl-tyrosine ([18F]FET), [18F]fluoromisonidazole ([18F]FMISO), and [18F]fluorothymidine ([18F]FLT).
METHODOLOGY: All the patients who were treated with high dose I-131from 18th January 2016 till 31st December 2016 in Hospital Pulau Pinang, Malaysia were recruited. The data from 126 patients on thyroxine hormone withdrawal (THW) group and 18 patients on recombinant human thyroid stimulating hormone (rhTSH) group were analysed. There is no change in patient management in terms of preparation, dose or post therapy whole-body scan. Fluid intake of patients were monitored strictly and whole-body retention of I-131are measured using ionizing chamber meter immediately after ingestion of I-131then at 1 hour, 24 hours, 48 hours, 72 hours and 96 hours.
RESULTS: The median time to achieve permissible release limit (50 μSV/hr at 1 meter) was 21.6 hours and 22.1 hours post-ingestion of I-131in the THW and rhTSH group respectively. The minimum amount of fluid needed to reach permissible release limit in the fastest time was 2,103 ml and 2,148ml for the THW and TSH respectively.
CONCLUSION: Clinicians would be able to evidently advise their patient on the amount of fluid to consume and utilize their isolation wards faster to treat more patients.