HPLC法测定琥珀酸噁泼西汀有关物质

Determination of Related Substances in Esreboxetine Succinate by HPLC

目的:制定测定琥珀酸噁泼西汀有关物质的高效液相色谱方法。方法:采用Waters Xselect CSH phenyl-hexyl(150 mm×4.6 mm,3.5μm)色谱柱进行分离。流动相为以0.1%的三氟乙酸水溶液为流动相A和0.1%的三氟乙酸乙腈溶液为流动相B,洗脱梯度为0-20 min,20%B-90%B,流速为0.9 ml/min,检测波长为210 nm。结果:琥珀酸噁泼西汀与各有关物质分离较好,在2.0148~100.74μg/ml浓度范围内呈线性相关,相关系数为0.99979。三批样品总杂含量分别为0.24%,0.10%,0.10%。结论:本法具有较高的灵敏度、精密性和特异性,适用于琥珀酸噁泼西汀有关物质检测。

Objective： To develop a method for the determination of related substances in esreboxetine succinate by high performance liquid chromatography with ultraviolet detection. Methods： The compounds were separated on a Waters Xselect CSH phenyl-hexyl （150 mm×4.6 mm, 3.5 μm） column. The mobile phase was composed of acetonitrile-water,both phase with 0.1%TFA. The gradient was 0-20 min, 20%B-90%B.The flow rate of mobile phase was 0.9 ml/min. The UV detection wave length was 210 nm. Results： Esreboxetine succinate and the related substances were well separated. The relationship of the peak area of esreboxetine succinate was linear within the range of 2.0148-100.74 μg/ml with coefficient correlation r=0.99979.The total impurities of three bathes of esreboxetine succinate was 0.24%, 0.10%, 0.10%, Conclusion：The method is sensitive ,precise ,reproducible and specific. And can be used for the determination of related substances in esreboxetine succinate.