高效液相色谱法测定巴柳氮片中主药的含量及检查有关物质

Determination of Balsalazide Tablet and Detection of Its Related Substances by HPLC

目的:建立以高效液相色谱法测定巴柳氮片中主药含量及检查有关物质的方法.方法:色谱柱为C18,流动相为0.1mol/L磷酸二氢胺-乙腈(82:18),流速为1.0ml/min,检测波长为360nm,柱温为40℃,进样量为10μl.结果:巴柳氮与有关物质可完全分离,其检测浓度在20.0～150.0μg/ml范围内与峰面积积分值线性关系良好(r=0.9 999);平均回收率为99.6%(RSD=1.19%).结论:本方法简便、快速、准确、专属性强、重现性好,且辅料对主药测定无干扰,可用于巴柳氮片的含量测定与有关物质检查.

OBJECTIVE：To establish a HPLC method for the determination of the principal agent in balsalazide tablets and detection of the related substances.METHODS： The determination was conducted on C18 column with column temperature at 40℃ .The mobile phase was composed of 0.1 mol/L ammonium dihydrogen phosphateacetonitrile（82 ： 18） with flow rate at 1.0ml/min and wavelength at 360nm.RESULTS： Balsalazide and its related substance could be absolutely separated through this method. The liner range of the balsalazide was 20.0-150.0μg/ml（ r = 0.9 999）. The average recovery was 99.6 % （RSD = 1.19%）.CONCLUSION ：The method was simple, fast, accurate, specific, reproducible and free from the interference of excipients in the determination of principal agent, and which can be adopted for the determination of the principal agent in balsalazide tablets and detection of the related substances.