Rao R Nageswara, Talluri M V N Kumar, Maurya Pawan K
Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad 500 607, India.
J Pharm Biomed Anal. 2009 Oct 15;50(3):281-6. doi: 10.1016/j.jpba.2009.04.038. Epub 2009 May 15.
A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for evaluating the chiral discrimination ability of CYCLOBOND I 2000 DM chiral stationary phase (CSP) towards sertraline and its related enantiomers. The effect of pH, buffer concentration as well as nature of organic modifier, flow rate and temperature on enantioselectivity was investigated. The developed reversed-phase chromatographic conditions were able to separate not only the enantiomers of sertraline but also its process related chiral impurities. The method was validated for determination of enantiomeric purity of sertraline HCl in drug substances and formulations.
建立并验证了一种反相高效液相色谱（HPLC）方法，用于评估CYCLOBOND I 2000 DM手性固定相（CSP）对舍曲林及其相关对映体的手性识别能力。研究了pH值、缓冲液浓度、有机改性剂的性质、流速和温度对 enantioselectivity 的影响。所建立的反相色谱条件不仅能够分离舍曲林的对映体，还能分离其工艺相关的手性杂质。该方法经过验证，可用于测定原料药和制剂中盐酸舍曲林的对映体纯度。
