高效液相色谱测定盐酸决奈达隆片含量及有关物质

HPLC determination of dronedarone hydrochloride tablets and its related substances

目的:应用高效液相色谱技术,建立盐酸决奈达隆片含量测定和有关物质检查的方法。方法:采用Agilent ZORBAX E-clipse Plus C18色谱柱(100 mm×4.6 mm,3.5μm),以2 mmol·L-1磷酸二氢钠溶液(以氢氧化钠溶液调至pH 7.0)-甲醇-乙腈(20∶30∶50)为流动相,流速1.5 mL·min-1,检测波长290 nm。结果:决奈达隆的线性相关系数(r)为1.000;检出限为0.19mg·L-1;回收率在101.4%～101.6%之间;精密度和12 h稳定性的RSD均小于1%;决奈达隆和辅料及强制降解产物之间都有良好的分离度。结论:该方法可作为盐酸决奈达隆片含量测定和有关物质检查的方法。

Objective： To establish an HPLC method for the determination of dronedarone hydrochloride tablets and its related substances. Method：An Agilent ZORBAX Eclipse Plus C ls column （100 mm ×4. 6 mm, 3.5 μm） was used for the separation, with 2 mmol ·L-1 sodium dihydrogen phosphate （adjusted pH to 7.0 with sodium hydrox- ide solution） - methanol - acetonitrile （20： 30： 50） as the mobile phase at the flow rate of 1.5 mL · min-1. The de- tection wavelength was 290 nm. Results： The correlation coefficient（r） of dronedarone was 1. 000; the LOD was 0. 19 mg · L-1 ;the spiked recovery ranged from 101.4% to 101.6% ;the relative standard deviations（RSDs） of the precisions and the 12 h stability were both below 1% ;satisfactory resolutions between dronedarone, excipients and forced degradation products were achieved. Conclusion： This method can be used for the determination of dronedarone hydrochloride tablets and its related substances.