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目的:采用高效液相色谱法研究茜草双酯的含量及有关物质的测定方法。方法:色谱柱为Eurospher 100-5 C_(18)色谱柱(250 mm×4.6 mm,5μm);柱温:室温;流动相为乙腈:0.05 mol·L~(-1)磷酸(二乙胺调pH=5)=70:30;流速为1.0 ml·min~(-1);紫外检测波长:264 nm。结果:在该条件下,茜草双酯主峰和杂质得到很好的分离,茜草双酯浓度在10～200μg·ml~(-1)范围内呈良好的线性,r=0.999 9;平均回收率为98.1%,RSD=0.73%;茜草双酯溶液在室温避光条件下放置5 h内保持稳定。结论:本法能准确测定茜草双酯有关物质及其含量,且方法简便,重复性好,可作为该产品的质量控制方法。
OBJECTIVE: To study the content of Rubiacetin and the determination of related substances by high performance liquid chromatography. METHODS: The column was Eurospher 100-5 C 18 column (250 mm × 4.6 mm, 5 μm). The column temperature was at room temperature. The mobile phase consisted of acetonitrile: 0.05 mol·L -1 phosphoric acid pH = 5) = 70: 30; flow rate 1.0 ml · min -1; UV detection wavelength: 264 nm. Results: Under this condition, the main peak and the impurities of madder were separated well. The concentration of madder was linear in the range of 10 ~ 200μg · ml ~ (-1), r = 0.999 9. The average recovery was 98.1%, RSD = 0.73%. Rubiacetate solution remained stable within 5 hours at room temperature in the dark. Conclusion: This method can accurately determine the relative content of Rubiacetin and its content, and the method is simple and reproducible, and can be used as the quality control method of the product.