高效液相色谱法检测非洛地平缓释片中的氧化产物

摘要

A HPLC method for determination of oxidation product in sustained-release tablets of felodipine was established. The chromatographic conditions were as follows;using C18 column(150mmX4.6mm,5μm), the mobile phase was acetonitrile-methanol-phosphate buffer solution(2:4:2)with pH value of 3.0.the determination wavelength was 254 nm,the flow rate was 1.5 mL·min-1.the determination concentration was 3μg·mL-1.the injection volume was 20 μL. The oxidation product concentration had good linear relationship with peak area-within the range of 0.1525-6.100μg·mL-1. The detection limit of oxidation product was 0.61 ng and the quantification limit was 1. 83 ng. The RSD of repeatability experiment was less than 1%. The average recovery was 98. 43%. The HPLC method was suitable for determining oxidation product in sustained-release tablets of felodipine with good repeatablility and stability.%建立了非洛地平缓释片中氧化产物的高效液相色谱检测法.色谱条件:C18色谱柱( 150 mm×4.6 mm,5μm),流动相为pH值3.0的乙腈-甲醇-磷酸盐缓冲溶液(2:1:2),检测波长254 nm,流速1.5 mL·min-1,检测浓度3μg· mL-1,进样量20 μL.氧化产物浓度在0.1525～6.100 μg·mL-1的范围内与峰面积线性关系良好,检测限为0.61 ng,定量限为1.83 ng；重复性实验相对标准偏差(RSD)均小于1％；平均回收率为98.43％.该方法重复性好、稳定性高,适合非洛地平缓释片中氧化产物的测定.