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

Alessia Rosetti; Rosella Ferretti; Leo Zanitti; Adriano Casulli; Claudio Villani; Roberto Cirilli

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

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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.

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《药物分析学报：英文版》 |2020年第6期|610-616|共7页
作者
Alessia Rosetti; Rosella Ferretti; Leo Zanitti; Adriano Casulli; Claudio Villani; Roberto Cirilli;
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作者单位

National Centre for the Control and Evaluation of Medicines;

Chemical Medicines Unit;

Istituto Superiore di Sanita(ISS);

Viale Regina Elena 299;

00161;

Rome;

Italy;

Department of Chemistry and Technology of Drugs;

Sapienza University of Rome;

00185;

Rome;

Italy;

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;

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原文格式 PDF
正文语种 chi
中图分类有机化学;
关键词
Chiralpak IG-3; Enantiomers; Diastereomers; Reversed-phase enantioselective HPLC; Sertraline HCl;

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

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