阿戈美拉汀不纯品中杂质相对校正因子的测定.pdfVIP

• 370 • 现代药物与临床 Drugs Clinic 第 27 卷 第 4 期 2012 年 7 月 阿戈美拉汀不纯品中杂质相对校正因子的测定 1 1 2 1* 1 王 祎 ，刘 颖 ，兰 静 ，韩建萍 ，田青松 1. 天津泰普药品科技发展有限公司，天津 300193 2. 天津市药品审评中心，天津 300191 摘 要：目的 测定阿戈美拉汀不纯品中杂质相对校正因子。方法 利用多个未知量联立方程法计算阿戈美拉汀杂质的相对 校正因子，并对本法进行对比验证。结果 计算出二氢阿戈美拉汀粗品和四氢阿戈美拉汀粗品的相对校正因子，即f 2=0.228 ， f 4=0.065 ，并利用相对校正因子计算供试品中各组分质量分数，确定杂质的定量方法。结论 该方法可用于检测含多个未知 校正因子组分的样品，省去阿戈美拉汀样品提纯的繁琐，为杂质定量方法的确定提供参考。 关键词：阿戈美拉汀；杂质；相对校正因子；联立方程法 中图分类号：R927.1 文献标志码：A 文章编号：1674 - 5515(2012)04 - 0370 - 04 Determination of relative correction factor of impurity in crude agomelatine 1 1 2 1 1 WANG Yi , LIU Ying , LAN Jing , HAN Jian-ping , TIAN Qing-song 1. Tianjin Taipu Pharmaceutical Science Technology Development Co., Ltd., Tianjin 300193, China 2. Tianjin Center for Drugs Evaluation, Tianjin 300191, China Abstract: Objective To determine the relative correction factor of impurity in crude agomelatine. Methods The combination of several unknown parameters was used to establish simultaneous equations for calculating relative correction factor of impurity in agomelatine, and this method was verified by contrast test. Results The relative correction factors of crude dihydroagomelatine and crude tetrahydroagomelatine were obtained by this method with f being 0.228 andf being 0.065. Based on relative correction factors , 2 4 content of each component in samples was calculated, and the quantitative methods of impurities were established. Conclusion This method could be used for determination of samples with multi relative correction factors without purifying and provide guidance for the quantitative method of impurity. Key words: agomelatine; impurity; relative correction factor; simultaneous equations 目前，相对校正因子不但对杂质的定量尤为重