摘要
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 establish an HPLC method for determination of rubidate and its related substances. Method: The sepa- ration was performed on Eurospher C1s(250 mm ×4. 6 mm,5 μm) column with acetonitrile and 0. 05 mol.L-1 phosphoric acid (70: 30) (adjusted pH to 5 with diethylamine) as mobil phase. The flow rate was 1.0 ml-min-~ and the wavelength was at 264 nm. Result: The rubidate and its related substances can be completely separated above-mentioned in chromatographic condition. The linear range was 10-200 ixg.m1-1 (r =0. 999 9). The recovery rate was 98.1% ,RSD = 0. 73%. Conclusion: The method has specificity,which is sensitive and reliable and can be used for quality control of the drug.
出处
《中国药师》
CAS
2010年第4期515-517,共3页
China Pharmacist
基金
咸宁学院科学研究基金资助项目(咸宁学院KY0732)