高效液相色谱法分析胸苷衍生物BOC-FLT含量

Determination of thymidine derivatives BOC-FLT by high performance liquid chromatography

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-301953，R^2=0．9995。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 simple and rapid method for determining the concentration of BOC -FLT.which is a labeling precursor of ^18F-FLT. METHODS The content of BOC-FLT was determinated by reversed phase HPLC using acetonitrile as solvent.acetonitrile/water 85/15 as mobile phrase and 235 nm as detect wavelength. RESULTS The retention time of the main peak was 6.6 rain,and that of impurity was 4. 5 min. The resolution of FLT- BOC and impurity was 〉 1.5. The cali bration curve was linear in the concentration range of 100 -500mg·L^-1 （y = 3E ＋ 06x- 301 953,R^2 =0. 999 5）. Detection Limit of BOC-FLT was 2.5 ng（S/N≥3） ,and that of impurity was 1.2 ng（S/N≥3）. CONCLUSION The method can provide effective means to the quality control of the drug with simple and credibility.