用加校正因子的主成分自身对照法测定苯扎贝特中杂质氯苯酪胺的含量

Determine the content of impurity chlorobenzoyltyramine in bezafibrate with the correction factor for the substance and impuri being examined

目的:建立加校正因子的主成分自身对照法测定苯扎贝特中杂质氯苯酪胺的含量。方法:通过方法学验证试验,证明所采用的高效液相色谱法外标法测定苯扎贝特中杂质氯苯酪胺的含量方法可行;再利用外标法,分别测定主成分苯扎贝特和杂质氯苯酪胺的保留时间,计算氯苯酪胺相对于苯扎贝特的相对保留时间,分别测定主成分苯扎贝特和杂质氯苯酪胺的线性方程,以斜率计算杂质氯苯酪胺相对于主成分苯扎贝特的校正因子;最终利用相对保留时间确定杂质氯苯酪胺的位置,用校正因子测定杂质氯苯酪胺的含量。结果:测得杂质氯苯酪胺相对于主成分苯扎贝特的相对保留时间为0.90,校正因子为1.2494。结论:用加校正因子的主成分自身对照法测定苯扎贝特中杂质氯苯酪胺的含量,方法可行。

Objective ：To establish a method using the correction factor to determine the content of impurity chlorobenzoyltyramine in bezafibrate. Method：By validat the analytical method to ensure that the external standard method of HPLC method to determine the content of impurity chlorobenzoyltyramine in bezafibrate meets the requirements for the intended analytical applications. Than, use the external standard method of HPLC method to determine the relative retention time between chlorobenzoyltyramine and bezafibrate;use the slope of linear equation to determine the Correction factor between chlorobenzoyltyramine and bezafibrate. At last, use the relative retention time to sure the position of chlorobenzoyltyramine;use the the correction factor to determine the content of impurity chlorobenzoyltyramine in bezafibrate. Results：The relative retention time between chlorobenzoyltyramine and bezafibrate is 0. 90;the correction factor between chlorobenzoyltyramine and bezafibrate is 1. 2494. Conclusion：The method using the correction factor between substance being examined and impurity to determine the content of impurity chloro- benzoyltyramine in bezafibrate is available.