高效液相色谱测定盐酸决奈达隆片含量及有关物质

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 Eclipse Plus C₁₈色谱柱(100 mm×4.6 mm,3.5 μm),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0.19 mg·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 C₁₈ 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 hydroxide solution)-methanol-acetonitrile (20: 30: 50) as the mobile phase at the flow rate of 1.5 mL·min^-1.The detection 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.

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