摘要
目的:建立测定豆腐果苷分散片的含量及有关物质的高效液相色谱法。方法:采用 Diamond C_(18)色谱柱(250 mm×4.6mm,5μm);流动相为1.11%醋酸水溶液-乙腈(85:15),流速为1.0 mL·min^(-1),检测波长270 nm。结果:豆腐果苷的浓度在1.98～39.6μg·mL^(-1)范围内线性良好(r=1.000);方法的最低检测限为0.05 ng(S/N=3);低、中、高3种浓度的回收率(n=3)分别为99.6%(RSD=0.8%),100.3%(RSD=0.6%),100.0%(RSD=0.6%);各杂质峰与主峰达到基线分离。结论:此法操作简便、灵敏、准确,重复性好,适用于豆腐果苷分散片的含量及有关物质的测定。
Objective： To establish an RP - HPLC method for determination of the content and related substances of helicid dispersible tablets. Methods： Diamond C18 chromatographic column （250mm×4.6mm,5μm） was used and the mobile phase consisted of 1.11% acetic acid solution - acetonitrile（85：15 ）with a flow rate of 1.0mL·min^-1, the UV detection wavelenth was set at 270 nm. Results：The calibration curve was linear within the range of 1.98 to 39.6μg·mL^-1 （ r =1.000） ;The lowest limit determination was 0.05 ng（ S/N = 3 ）. The mean recoveries（ n = 3 ） of high,middle and low concentration were 100.0% （ RSD = 0.8% ）, 100.3% （RSD = 0. 6% ）, 99.6% （ RSD = 0.6% ） ;The chromatographic peaks of helicid and its related substances were well isolated. Conclusion：The method is simple, selective, accurate, reproducible. It is suitable for determination of the content and related substances of helicid dispersible tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第3期417-420,共4页
Chinese Journal of Pharmaceutical Analysis
