Evidence map›Paper›PMID 40089734›Full record

ArticleBMC chemistry2025

Integrating green analytical chemistry and analytical quality by design: an innovative approach for RP-UPLC method development of ensifentrine in bulk and inhalation formulations.

Mohan Goud Vanga, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Bayapa Reddy Narapureddy, Chandrashekar Thalluri

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Article in BMC chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

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3citing papers in PubMed
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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

3 citing papers in PubMed.

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4 · The record

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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.

Mohan Goud VangaDepartment of Pharmaceutical Analysis, Joginpally BR Pharmacy College, Hyderabad, Telangana, 500075, India.
Sarad Pawar Naik BukkeDepartment of Pharmaceutics and Pharmaceutical Technology, Kampala International University, Western Campus, P. O. Box 71, Ishaka-Bushenyi, Uganda. drsaradpawar@kiu.ac.ug.ORCID http://orcid.org/0000-0002-5693-2953
Praveen Kumar KusumaDepartment of Pharmaceutical Chemistry, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi, India. praveenkumarkusuma@dpsru.edu.in.ORCID http://orcid.org/0000-0002-0854-3734
Bayapa Reddy NarapureddyDepartment of Public Health, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.
Chandrashekar ThalluriDepartment of Pharmacy Faculty of Pharmaceutical Sciences, Assam Down Town University (AdtU), Guwahati, 781026, Assam, India.

Funding

Large Research Project RGP2/530/45
6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) is a significant global health issue, worsened by pollution and modernisation. Ensifentrine (EFT), a new dual inhibitor of phosphodiesterase PDE3 and PDE4, is being developed for inhalation to target airway inflammation, bronchodilation, and ciliary function in COPD treatment.

objectiveThis study aims to develop and validate a new quantification method for Ensifentrine, as no previous techniques are available, by integrating analytical quality-by-design (AQbD) and green analytical chemistry (GAC) principles.

methodsAn AQbD framework, utilizing Design-expert

resultsThe statistical analysis confirmed the model's significance and normal distribution. The method, validated according to ICH guidelines, showed good linearity (r GREEN CHEMISTRY ASSESSMENT: The greenness of the developed method was evaluated using tools such as ComplexMoGAPI, AGREE, BAGI, Green certificate-modified Eco-scale, and ChlorTox Scale. Additionally, the EVG method evaluation tool was also used to assess environmental impact, with the results shown in a radar chart.

conclusionThis study presents a sensitive and robust RP-UPLC method for quantifying Ensifentrine, combining AQbD and GAC principles. The method, validated according to ICH guidelines, also ensures environmental sustainability. This approach sets a precedent for future analytical method development in pharmaceutical sciences with a focus on sustainability.

Indexed as

Analytical quality-by-design (AQbD)ChlorTox scaleComplexMoGAPIEnsifentrineRP-UPLCSustainability in laboratories

Identifiers

PMID40089734
PMCPMC11909822

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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.