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目的建立RP-HPLC法同时测定普罗布考片中3种有关物质的含量。方法采用RP-HPLC加校正因子的主成分自身对照法,以普罗布考为参照物,分别测定其与有关物质A、B、C间的相对保留时间及相对校正因子,以校正因子对普罗布考片中的3种有关物质进行定量分析,并与外标法测定结果比较,以验证方法的准确性。结果有关物质A、B、C相对于主成分普罗布考的相对保留时间分别为1.46、0.93和1.40;相对校正因子分别为0.23、1.10和1.55;校正因子法与外标法测定的结果无显著性差异。结论本方法能够准确测定普罗布考片中3种有关物质的含量。
Objective To establish a RP-HPLC method for simultaneous determination of three related substances in probucol tablets. Methods The principal components of RP-HPLC plus calibration factor self-control method, with probucol as a reference substance, were measured relative retention time and related substances A, B, C and relative correction factor to correction factor Probus The three related substances in the test sample were quantitatively analyzed and compared with the results of the external standard method to verify the accuracy of the method. Results The relative retention time of the related substances A, B and C relative to the principal component probucol were 1.46, 0.93 and 1.40, respectively, and the relative correction factors were 0.23, 1.10 and 1.55 respectively. There was no significant difference between the calibration factor method and the external standard method Sex differences. Conclusion This method can accurately determine the content of three related substances in probucol tablets.