【摘要】 目的:建立阿雷地平对映异构体高效液相色谱手性拆分方法,用于S构型阿雷地平光学纯度的分析测定。方法:采用硅胶表面涂敷有纤维素-三（4-甲基苯甲酸酯）填料（Chiralcel OJ-H）为固定相,以正己烷-乙醇（75∶25）为流动相,流速1.0 m L·min^-1,检测波长238 nm,柱温35℃。结果:S-阿雷地平与R-阿雷地平之间的分离度为3.5;R-阿雷地平质量浓度在0.04².0μg·m L^-1范围内线性关系良好,线性方程为A=61 971C-0.321 4,r=0.999 9;R-阿雷地平的定量限和检测限分别为0.8 ng和0.3 ng;低、中、高3个浓度的R-阿雷地平回收率（n=3）分别为97.5%、98.5%、99.8%,RSD（n=9）为1.5%;供试品溶液在避光条件下室温放置12 h内稳定性良好。经检测,S-阿雷地平中R-阿雷地平的含量为0.08%。结论:所建立的方法经方法验证可用于分离和测定S-阿雷地平中的R-阿雷地平。更多还原

【Abstract】 Objective:To establish an HPLC method to separate aranidipine enantiomers for optical purity detection of S-aranidipine.Methods:The method was performed on a Chiralcel OJ-H column [cellulose tri（4-methylbenzoate）chiral stationary phase].The mobile phase was n-hexane-ethanol（75∶25）at a flow rate of 1.0 m L·min^-1.The column temperature was 35 ℃ and the detection wavelength was 238 nm.Results:The resolution between the peaks of S-aranidipine and R-aranidipine was 3.5.The method was found to show good linearity over the concentration range of 0.04-2.0 μg·m L^-1.The linear equation was A=61 971C-0.321 4,and the regression coefficient was 0.999 9.The limit of quantification and limit of detection of R-aranidipine were 0.8 ng and 0.3 ng,respectively.The recoveries of R-aranidipine（n=3）were 97.5%,98.5%,and 99.8% respectively at the concentration level of low,medium and high,with the RSD（n=9）of 1.5%.The test solution was stable for at least 12 h at 25 ℃ away from light.The R-aranidipine content in S-aranidipine sample was 0.08%.Conclusion:With good resolution and repeatability,the method can be reliably used for chiral separation of aranidipine,and for determination of the optical purity of S-aranidipine.更多还原