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

doi:10.1016/j.jpha.2020.11.002

Volume 10 Issue 6

Dec. 2020

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Alessia Rosetti, Rosella Ferretti, Leo Zanitti, Adriano Casulli, Claudio Villani, Roberto Cirilli. Single-run reversed-phase HPLC method for determining sertraline content, enantiomeric purity, and related substances in drug substance and finished product[J]. Journal of Pharmaceutical Analysis, 2020, 10(6): 610-616. doi: 10.1016/j.jpha.2020.11.002

Citation:

Alessia Rosetti, Rosella Ferretti, Leo Zanitti, Adriano Casulli, Claudio Villani, Roberto Cirilli. Single-run reversed-phase HPLC method for determining sertraline content, enantiomeric purity, and related substances in drug substance and finished product[J]. Journal of Pharmaceutical Analysis, 2020, 10(6): 610-616. doi: 10.1016/j.jpha.2020.11.002

Citation:

Alessia Rosetti, Rosella Ferretti, Leo Zanitti, Adriano Casulli, Claudio Villani, Roberto Cirilli. Single-run reversed-phase HPLC method for determining sertraline content, enantiomeric purity, and related substances in drug substance and finished product[J]. Journal of Pharmaceutical Analysis, 2020, 10(6): 610-616. doi: 10.1016/j.jpha.2020.11.002

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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

doi: 10.1016/j.jpha.2020.11.002

a. National Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, 00161, Rome, Italy;
b. Department of Chemistry and Technology of Drugs, Sapienza University of Rome, 00185, Rome, Italy;
c. WHO Collaborating Centre for the Epidemiology, Detection and Control of Cystic and Alveolar Echinococcosis, European Union Reference Laboratory for Parasites, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, 00161, Rome, Italy

Funds:

The authors are grateful to Ms. Antonina Mosca (Istituto Superiore di Sanità) for her technical assistance and Dr. Paolo Vatta (Istituto Superiore di Sanità) for improving the English language of the manuscript.

Received Date: Apr. 14, 2020
Accepted Date: Nov. 03, 2020
Rev Recd Date: Nov. 03, 2020
Available Online: Jan. 24, 2022
Publish Date: Dec. 10, 2020

Abstract

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 Medicines Control Laboratory and applied to control the content of sertraline HCl and related chiral substances in a generic antidepressant formulation.
- Chiralpak IG-3,
- Enantiomers,
- Diastereomers,
- Reversed-phase enantioselective HPLC,
- Sertraline HCl

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References(18)

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