摘要
目的:建立以RP-HPLC法测定黄豆苷元片含量及其有关物质的方法。方法:色谱柱Hypersil ODS-C_(18)(250 mm×4.6mm,5μm),流动相为甲醇-水-磷酸(50:50:0.1),流速为1.0 ml·min^(-1),检测波长为249 nm,进样量为20μl。结果:黄豆苷元的线性范围为1.0～270.0μg·ml^(1)(r=0.999 8);最低检测限为0.125μg·ml^(-1);平均回收率为99.88%,RSD=1.67%。结论:本方法快捷、简便、准确、专属性强,辅料不干扰主药测定,可用于黄豆苷元片的质量控制以及考察该制剂生产、贮藏、稳定性试验过程中的杂质变化情况。
Objective： To develop an HPLC method for determining content and its related substances in daidzein tablets. Method： The HPLC method was performed on a Hypersil ODS-C18 （250 mm ×4. 6 mm,5 μm） ,with mobile phase consisted of methanol-water-phosphoric acid （50： 50： 0. 1 ）. The flow rate was 1.0 ml.min^-1. The detection wavelength was 249 nm and the injection volume was 20 μl. Result： A good linear relationship of daidzein was obtained with the range of 1.0-270.0 μg·ml^-1 （r =0. 999 8）. The lowest detection limit was 0. 125μg·ml^-1. The average recovery was 99. 88% （RSD = 1.67% ）. Conclusion： The method is quick, simple and accurte, and suitable for the quality control of daidzein tablets.
出处
《中国药师》
CAS
2010年第3期376-378,共3页
China Pharmacist
