高效液相色谱法检测非洛地平缓释片中的氧化产物

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20μL。氧化产物浓度在0.1525～6.100μg.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。

Determination of Oxidation Product in Sustained-Release Tablets of Felodipine by HPLC Method

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（150 mm）4.6 mm,5 fire）, the mobile phase was acetonitrile-methanol-phosphate buffer solution（2 ： 1 ＂ 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 3 ug . mL-1 , the injection volume was 20 uL. The oxidation product concentration had good linear relationship with peak area ,within the range of 0. 1525-6. 100ug . 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.