Single-run reversed-phase HPLC method for determining sertraline content,enantiomeric purity,and related substances in drug substance and finished product  

作　　者：Alessia Rosetti Rosella Ferretti Leo Zanitti Adriano Casulli Claudio Villani Roberto Cirilli 

机构地区：[1]National Centre for the Control and Evaluation of Medicines,Chemical Medicines Unit,Istituto Superiore di Sanita(ISS),Viale Regina Elena 299,00161,Rome,Italy [2]Department of Chemistry and Technology of Drugs,Sapienza University of Rome,00185,Rome,Italy [3]WHO Collaborating Centre for the Epidemiology,Detection and Control of Cystic and Alveolar Echinococcosis,European Union Reference Laboratory for Parasites,Istituto Superiore di Sanita(ISS),Viale Regina Elena 299,00161,Rome,Italy

出　　处：《Journal of Pharmaceutical Analysis》2020年第6期610-616,共7页药物分析学报（英文版）

摘　　要：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.

关 键 词：Chiralpak IG-3 ENANTIOMERS DIASTEREOMERS Reversed-phase enantioselective HPLC Sertraline HCl 

分 类 号：O657.72[理学—分析化学] R927.11[理学—化学]