HPLC法测定放射增敏剂苯并三嗪衍生物YABQ含量及有关物质

Determination of content and related substances of radiosensitizer benzotriazine derivatives YABQ by HPLC

目的建立测定放射增敏剂YABQ含量及有关物质的高效液相色谱检测方法。方法采用Diamonsil C_（18）（250 mm×4.6 mm,5μm）色谱柱;流动相为甲醇-0.1%甲酸（22∶78）等度洗脱;流速1.0 ml/min;检测波长266 nm;柱温30℃;进样体积10μl。结果运用上述色谱方法进行检测,YABQ在7-84μg/ml的范围内线性关系良好（r=0.9992）;该化合物检测限响应值为8 ng（信噪比S/N≥3）,定量限响应值为24 ng（信噪比S/N≥10）;经破坏性试验,各色谱峰间分离度良好（〉1.5）,说明该色谱法满足试验要求。结论经方法学验证及破坏性试验,该法精密度高,专属性良好,可用于YABQ及其有关物质的质量控制。

Objective To establish an HPLC method for determination of the content of radiosensitizer YABQ and its related substances. Methods Diamonsil C18column（ 250 mm × 4. 6 mm,5 μm） was used. The mobile phase consisted of methanol- 0. 1% formic acid（ 22∶ 78） and isocratic elution at a flow rate of 1. 0 ml / min. The detection wavelength was 266 nm,the temperature of the column was 30℃,and the injection volume was 10 μl. Results The linear range of YABQ was7- 84 μg / ml,r = 0. 9992. The detection limit was 8 ng（ S / N≥3）,and the quantitation limit was 24 ng（ S / N≥10）.According to destructive sample processing,the separation coefficient between the peaks was above 1. 5,indicating that this chromatographic method could meet the YABQ monitoring requirements. Conclusion Method validation and destructive testing show that both the precision and specificity are fine with this method,which could be used for quality control of YABQ and its related substances.