Assessing the influence of neglected GC-FID variables on the multiple responses using multivariate optimization for the determination of ethanol and acetonitrile in radiopharmaceuticals

Abstract Analytical gas chromatography in line with a flame ionization detector (GC-FID) method was developed and validated for direct determination of organic solvents [ 18 F]fluoro-ethyl-tyrosine ([ F]FET), F]fluoromisonidazole F]FMISO) F]fluorothymidine F]FLT). Variables the splitless time (min) injection temperature ( ° C) on response analysis resolution were optimized assistance two-level full factorial design desirability function Derringer. The proposed procedure following International Council Harmonisation Technical Requirements Pharmaceuticals Human Use (ICH) Q2 (R1) guideline. Excellent linearity, R 2 > 0.990, indicated that approximately 99% variance could be predicted from ethanol acetonitrile concentrations ranging 0.5 to 6.0 mg mL −1 0.1 0.8 , respectively. has proved selective, sensitive, accurate (90–110%), excellent repeatability precision (RSD < 2%). In robustness analysis, findings calculated Standardized Effects Values (SE) insignificant p 0.05) demonstrated robust 1.0 ± min an 210 10 °C. also successfully used quantitative F]FET, F]FMISO, F]FLT. Both well separated (R, 4.1–4.3) within 4.5 min. Therefore, is relevant routine quality control all F-radiopharmaceutical derivatives acetonitrile.