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作 者:周杏琴[1] 陆春雄[1] 钦晓峰[1] 张建康[1] 曹国宪[1]
机构地区:[1]江苏省原子医学研究所,卫生部核医学重点实验室,江苏省分子核医学重点实验室,江苏无锡214063
出 处:《中国医院药学杂志》2011年第6期464-466,共3页Chinese Journal of Hospital Pharmacy
基 金:国家自然科学基金项目(编号:30770602);江苏省自然科学基金项目(编号:BK2008112)
摘 要: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.
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