HPlC法测定苯磺酸左旋氨氯地平片的含量及有关物质

Determination of levamLodipine Besylate Tablets and Related Substances by HPlC

目的:建立反相高效液相色谱法测定苯磺酸左旋氨氯地平片的含量及有关物质。方法:采用十八烷基硅烷键合硅胶填充柱(Apollo C18,5μm,250mm×4.6mm),甲醇-0.03mol/L磷酸二氢钾溶液(75∶25)为流动相,检测波长为238nm,流速为1.0mL/min,柱温为室温。结果:主成分与其余杂质峰完全分离,苯磺酸左旋氨氯地平溶液在2.448μg/mL-122.4μg/mL浓度范围内呈良好的线性关系,相关系数为0.9999,平均回收率为99.1%,RSD为0.8%,最小检出量为1.67ng,方法精密度良好(RSD=0.4%)。结论:该方法专属性强,精密度、准确度符合要求,方法可靠,可用于苯磺酸左旋氨氯地平片的含量测定及有关物质检查。

Objective ：To Determinate levamlodipine besylate tablets and related substances by rp HP1C. Methods ：The eighteen alkyl si- lane bonded silica gel packed column（ Apollo Cjs ,250mm x4.6mm,5μ m） ,Methanol -0.03mol/L potassium dihydrogen phosphate （75： 25 ） as the mobile phase, The detection wavelength was 238nm, the flow rate was 1. OmL/min, column temperature was at room tempera- ture. ResuLts： Principal component completely separated from other impurity peak, levamLodipine besylate solution at 2.448p.g/mL to 122.4p.g/mL concentration range showed a good linear relationship, the correlation coefficient was 0. 9999, the average recovery was 99. 1%, RSD was 0.8%, The minimum detectable amount is 1.67ng, the precision of the method is good （ RSD = 0.4% ）, Conclusion The method has high specificity, precision, accuracy, reliable method, can be used for the determination of levamLodipine besylate tablets of the content and the related substances.