RP-HPLC法测定粉针剂中两头尖皂苷D的含量

Determination of anemone raddeana saponin D in powder injection by RP-HPLC

【目的】建立测定注射用粉针剂中两头尖皂苷D含量的反相高效液相色谱法。【方法】采用HypersilODS色谱柱(4.6mm×200mm,5μm),流动相甲醇-水(80:20),流速1.0ml/min,检测波长206nm。【结果】两头尖皂苷D进样量在2.4～12.0μg范围内线性关系良好。平均回收率为99.34%,RSD为1.41%。【结论】本法简便快速准确,可作为注射用ASD的质量控制方法。

[Objective] To establish a RP-HPLC method for the determination of anemone raddeana saponin D（ASD） in the ASD injection. [Method] A RP-HPLC method was applied with a Hypersil ODS （4.6mm×200mm,5μm） column using MeOH-H2O（80： 20）as the mobile phase. The flow rate was 1.0 ml/min and the detection wavelength was 206 nm. [ Results] The calibration curves of ASD were linear at the ranges of 2.4 - 12.0 μg. The average recovery was 99.34% （RSD 1.41%）. [Conclusions] This method had been successfully applied to determine the content of ASD in ASD injection. This method is simple, rapid and accurate. It can be used for the quality control of ASD injection.