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目的:建立一种HPLC法分析正电子发射断层(PET)肿瘤诊断药物18F-FLT标记前体BOC-FLT的含量,为药盒质量控制提供有效的检测手段。方法:乙腈作为溶剂,235nm作为检测波长,乙腈-水(85∶15)作流动相,HPLC法分析BOC-FLT含量。结果:主峰保留时间为6.6min,杂质峰保留时间为4.5min,分离度大于1.5,BOC-FLT在100~500mg.L-1试验范围内呈良好的线性关系,回归方程为y=3E+06x-301 953,R2=0.999 5。FLT-BOC最小检出量为2.5ng(S/N≥3);杂质最小检出量为1.2ng(S/N≥3)。结论:方法简便、可靠,重复性好,能够为药盒的质量控制提供有效的分析手段。
OBJECTIVE: To establish a HPLC method for the analysis of the BOC-FLT content of the 18F-FLT labeled precursor of the PET tumor diagnostic reagent, and to provide an effective detection method for the quality control of the kit. METHODS: Acetonitrile as solvent, 235 nm as detection wavelength, acetonitrile-water (85:15) as mobile phase, HPLC analysis of BOC-FLT content. Results: The main peak retention time was 6.6min, impurity peak retention time was 4.5min, resolution was greater than 1.5, BOC-FLT in the range of 100 ~ 500mg.L-1 showed a good linear relationship, the regression equation was y = 3E + 06x -301 953, R2 = 0.999 5. The minimum detection volume of FLT-BOC is 2.5ng (S / N≥3). The minimum detectable amount of impurities is 1.2ng (S / N≥3). Conclusion: The method is simple, reliable and reproducible. It can provide an effective analytical tool for the quality control of kits.