【摘要】 目的:建立高效液相色谱法测定盐酸雷诺嗪的含量和有关物质。方法:采用 Agilent ZORBAX 300-SCX 阳离子交换柱（250 mm×4.6 mm,5 μm）,以乙腈-0.02 mol·L^-1磷酸二氢钾（45:55,磷酸调 pH 3.0）为流动相,流速为1.0 mL·min^-1,用外标法测定,检测波长为233 nm,柱温为30℃。结果:在2.00～20.48 μg范围内,色谱峰面积与进样量呈良好的线性关系,线性回归方程为:Y=788.5X+106.4（r=0.9999）;最小检测量为2 ng。结论:本法准确、简便、灵敏,可用于盐酸雷诺嗪的含量测定和有关物质检查。更多还原

【Abstract】 To establish an HPLC method for the determination of content and related substances of ranolazine hydrochloride.Method:The Agilent ZORBAX 300-SCX column（250mm×4.6 mm,5 μm）was used, the mobile phase was acetonitrile-0.02 mol·L^-1 potassium dihydrogen phosphate（45:55,adjusted pH to 3.0 with phosphoric acid）.The detection wavelength was 233 nm and column temperature was 30℃.Ranolazine hydrochloride was measured with external standard method.Results:The calibration curve was linear in the range of 2.00-20.48μg（r=0.9999）.The limit of detection was 2 ng.Conclusion:This method is accurate,simple and sensitive,and it can be used for the assay and related substances control of ranolazine hydrochloride.更多还原