Evidence map›Paper›PMID 32863397›Full record

ArticleChromatographia2020

Stability Indicating LC Method Development for Hydroxychloroquine Sulfate Impurities as Available for Treatment of COVID-19 and Evaluation of Risk Assessment Prior to Method Validation by Quality by Design Approach.

Thirupathi Dongala, Naresh Kumar Katari, Ashok Kumar Palakurthi, Lakshmi Narasimha Rao Katakam, Vishnu Murthy Marisetti

Open access · bronzeAbstract read
In one paragraph

Article in Chromatographia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

2 citing papers in PubMed, 26 citations in OpenAlex.

  1. Article
  2. Article
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

5 authors at 3 institutions in 2 countries.

Thirupathi DongalaAnalytical Research and Development, Aurex Laboratories LLC, 10 lake drive, East windsor, New Jersey 08520 USA.ORCID 0000-0001-8251-5005
Naresh Kumar KatariDepartment of Chemistry, GITAM University, Hyderabad, Telangana 502329 India.
Ashok Kumar PalakurthiAnalytical Research and Development, Aurex Laboratories LLC, 10 lake drive, East windsor, New Jersey 08520 USA.
Lakshmi Narasimha Rao KatakamAnalytical Development, Saptalis Pharmaceuticals LLC, Hauppauge, NY 11788 USA.
Vishnu Murthy MarisettiAnalytical Research and Development, ScieGen Pharmaceuticals Inc, 89 Arkay drive, Hauppauge, NY 11788 USA.
United Biomedical (United States) · USUniversity of Hyderabad · INAnalytical Engineering (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A quality by design-based stability indicating HPLC method has been developed for hydroxychloroquine sulfate impurities. The optimized HPLC method can detect and quantify the hydroxychloroquine sulfate and related organic impurities in pharmaceutical solid oral dosage forms. Nowadays, for the quantification of impurities in drug products demands more comprehensive way of analytical method development. The quality by design approach allows the assessment of different analytical parameters and their effects with minimum number of experiments. A highly sensitive and stability indicating RP-HPLC method was developed and evaluated the risk assessment prior to method validation. The chromatographic separation was achieved with X-terra phenyl column (250 × 4.6 mm, 5 µm) using phosphate buffer (0.3 M and pH 2.5). The gradient method flow rate was 1.5 mL min

Indexed as

Design of experimentsHPLCHydroxychloroquine sulfateQuality by designValidation

Identifiers

PMID32863397
PMCPMC7445446
OpenAlexW3080570430

What OpenQuestion holds

Textmetadata
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.