高效液相色谱法测定苦参素注射液中氧化槐果碱杂质含量

HPLC Determination of Oxysophocarpine in Marine Injection

目的建立高效液相色谱法测定苦参素注射液中氧化槐果碱杂质含量。方法采用Discovery C18（4.6 mm×250 mm,5μm）色谱柱;流动相：pH3.0磷酸盐缓冲液-乙腈-甲醇（94∶5∶1）;流速：1.0 mL.min-1;检测波长：220 nm;柱温：（40±1）℃。结果能准确检出苦参素中0.1%-2.0%限度范围的氧化槐果碱杂质,平均回收率99.24%。结论HPLC测定苦参素注射液中氧化槐果碱杂质含量灵敏、准确,可用于本品的质量控制。

OBJECTIVE To establish a HPLC method for the determination of Oxysophocarpine in Marine Injection.METHODS The HPLC determination was carried out on a Discovery C18（4.6 mm×250 mm,5 μm） column at temperature of（40±1）℃,using a UV detector and the detection wavelength was 220 nm.Elution was carried out with pH 3.0 Phosphate Buffer-acetonitrile-methanol（95∶4∶1） at a flow rate of 1.0 mL·min-1. RESULTS The linearity of the determination of Oxysophocarpine in Marine was over the range of 0.1%～2.0% and the average recovery of Oxysophocarpine was 99.24%.CONCLUSION The HPLC method shows a good separation and accuracy and it could be used for quality control to determine Oxysophocarpine in Marine Injection.