A direct enantio-, diastereo-, and chemo-selective high-performance liquid chromatographic method was developed for determining the content, enantiomeric purity, and related substances of the chiral antidepressant drug sertraline HCl in a single chromatographic run. The separation was achieved on a chiral stationary phase based on amylose tris(3-chloro-5-methylphenylcarbamate) under reversed-phase conditions. The method was optimized by evaluating the influence of the temperature and mobile phase composition on the retention and selectivity. The application of the single-run approach allowed to baseline resolve all investigated species in less than 15 min, without using buffers or tandem-coupled columns. The chromatographic method was validated according to the guidelines of the Official Medicines Control Laboratory and applied to control the content of sertraline HCl and related chiral substances in a generic antidepressant formulation.

开发了一种直接对映，非对映和化学选择性的高效液相色谱方法，用于在一次色谱分析中测定手性抗抑郁药舍曲林盐酸盐的含量，对映体纯度和相关物质。在反相条件下，在基于直链淀粉三（3-氯-5-甲基苯基氨基甲酸酯）的手性固定相上实现分离。通过评估温度和流动相组成对保留时间和选择性的影响，对该方法进行了优化。单次运行方法的应用允许在不到15分钟的时间内对所有研究的物种进行基线分析，而无需使用缓冲液或串联色谱柱。