Single-run reversed-phase HPLC method for determining sertraline content, enantiomeric purity, and related substances in drug substance and finished product
- Author:
Rosetti ALESSIA
1
;
Ferretti ROSELLA
;
Zanitti LEO
;
Casulli ADRIANO
;
Villani CLAUDIO
;
Cirilli ROBERTO
Author Information
1. National Centre for the Control and Evaluation of Medicines,Chemical Medicines Unit,Istituto Superiore di Sanit(a) (ISS),Viale Regina Elena 299,00161,Rome,Italy;Department of Chemistry and Technology of Drugs,Sapienza University of Rome,00185,Rome,Italy
- Keywords:
Chiralpak IG-3;
Enantiomers;
Diastereomers;
Reversed-phase enantioselective HPLC;
Sertraline HCl
- From:
Journal of Pharmaceutical Analysis
2020;10(6):610-616
- CountryChina
- Language:Chinese
-
Abstract:
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 Medi-cines Control Laboratory and applied to control the content of sertraline HCl and related chiral sub-stances in a generic antidepressant formulation.
