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.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
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)
关键词
高效液相色谱
BOC-FLT
含量
high performance liquid chromatography
BOC-FLT
content