Evidence map›Paper›PMID 33425455›Full record

ArticleJournal of pharmaceutical analysis2020

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

Open access · goldAbstract read
In one paragraph

Article in Journal of pharmaceutical analysis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.5field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Chirality of antidepressive drugs: an overview of stereoselectivity.Asian biomedicine : research, reviews and news · 2022
    Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Alessia RosettiNational Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, 00161, Rome, Italy.
Rosella FerrettiNational Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, 00161, Rome, Italy.
Leo ZanittiNational Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, 00161, Rome, Italy.
Adriano CasulliWHO 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.
Claudio VillaniDepartment of Chemistry and Technology of Drugs, Sapienza University of Rome, 00185, Rome, Italy.
Roberto CirilliNational Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Istituto Superiore di Sanità (ISS), Viale Regina Elena 299, 00161, Rome, Italy.
Istituto Superiore di Sanità · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Chiralpak IG-3DiastereomersEnantiomersReversed-phase enantioselective HPLCSertraline HCl

Identifiers

PMID33425455
PMCPMC7775844
OpenAlexW3096711695

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.