[18F]Florastamin放射化学纯度HPLC分析方法研究OA

This study aims to develop and validate a reliable analytical method for the precise determination of the radiochemical purity(RCP)of[18F]Florastamin,an 18F-labeled radiopharmaceutical targeting prostate-specific membrane antigen(PSMA).Accurate RCP assessment is a critical quality control requirement to ensure the safety,diagnostic efficacy,and batch-to-batch consistency of radiopharmaceuticals for clinical use.Therefore,establishing a robust and validated method is essential for supporting its pharmaceutical development and regulatory compliance.A reversed-phase high-performance liquid chromatography(HPLC)method was established.Separation was achieved using a chromatographic column packed with octadecylsilyl-bonded silica gel(ø4.6 mm×250 mm,5 μm particle size).The mobile phase consisted of trifluoroacetic acid(TFA)-water(volume ratio 0.05∶100)solution(mobile phase A)and trifluoroacetic acid-acetonitrile(volume ratio 0.05∶100)solution(mobile phase B),delivered via a gradient elution program.The analysis was performed under the following conditions:column temperature of 25 ℃,injection volume of 20 μL,flow rate of 1.00 mL/min,and a total runtime of 31 minutes.Detection was accomplished using a tandem system comprising a UV-Vis detector set at 220 nm and a radioactive flow detector.The method was rigorously validated according to standard protocols to evaluate its performance.The method provides excellent separation,effectively resolving the main radioactive peak corresponding to[18F]Florastamin from adjacent radiochemical impurities with a resolution exceeding 1.5.It demonstrates excellent linearity(correlation coefficient r=1.000)across a broad radioactivity concentration range from 0.32 to 172.36 GBq/L.The limit of detection and limit of quantification are determined to be 9.60×10-2 GBq/L and 3.20×10-1 GBq/L,respectively.All validation parameters,including precision and robustness,meet the accepted analytical requirements,and confirm the method's reliability and reproducibility.This study successfully establishes a fully validated HPLC method for the determination of RCP of[18F]Florastamin.The method is specific,linear,precise,and robust.It provides a critical and reliable technical tool for quality control,supports the establishment of official standards and ensures the consistent production of[18F]Florastamin for clinical application.This methodological framework also offers a valuable reference for the analysis of other similar 18F-labeled PSMA-targeted radiopharmaceuticals.