HPLC测定毛兰素乳液型注射液中毛兰素及有关物质含量

目的建立一种测定一类新药毛兰素乳液型注射液中毛兰素及有关物质鼓槌联苄含量的方法。方法采用AgilentXDBC18柱（4.6mm×250mm,5μm）,流动相为甲醇-乙腈-水（30∶30∶40）,检测波长：232nm;流速：1.0mL·min-1。结果毛兰素及有关物质鼓槌联苄达到完全分离;毛兰素在5.5625~89.0μg·mL-1内线性关系良好（Y=13504X＋2146.6,r=0.9999）,平均回收率100.8%;有关物质鼓槌联苄在9.292~46.462μg·mL-1内亦有良好线性关系（Y=14.0331X＋2.3886,r=0.9999）,平均回收率达99.8%。结论本法灵敏,准确,专属性强,可用于测定注射液中毛兰素的含量和有关物质的检查。

Determination of Erianin and Its Related Constituent Chrysotobibenzyl in Erianin Emulsion Injection by HPLC

OBJECTIVE To establish an HPLC method for determining the contents of erianin and related constituent chrysotobibenzyl in Erianin emulsion injection. METHODS Agilent EclipseXDB-C18 column（4.6 mm×250 mm, 5 μm） was used. The mobile phase consisted of methanol-acetonitrile-water（30∶ 30∶ 40）, the flow rate was 1.0 mL·min-1, and the detective wavelength was 232 nm. RESULTS Erianin and its related constituent chrysotobibenzyl were separated completely in Erianin emulsion injection. The calibration curves of both erianin and chrysotobibenzyl showed good linearity in the range of 5.562 5-89.0 μg·mL-1 and 9.292？46.462 μg·mL-1, respectively（erianin： Y=13 504X＋2 146.6, r=0.999 9; chrysotobibenzyl： Y=14.033 1X＋2.388 6, r=0.999 9）. The average recovery of erianin and chrysotobibenzyl was 100.8% and 99.82%, respectively. CONCLUSION The method is accurate, sensitive and with high specific, it can be applied for determining the contents of erianin as well as its related constituent chrysotobibenzyl in Erianin emulsion injection.