Evidence map›Paper›PMID 39558405›Full record

ArticleBMC chemistry2024

AQbD-enhanced green RP-UPLC-PDA methodology for quantification and forced degradation studies for omeprazole, amoxicillin, and rifabutin.

S P Ashnah Baffinsha, Vijayageetha Ragupathi, Hemanth Kumar Chanduluru

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Article in BMC chemistry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

S P Ashnah BaffinshaDepartment of Pharmaceutical Analysis, C.L Baid Metha College of Pharmacy, Thoraipakkam, Chennai, 6000097, India.
Vijayageetha RagupathiDepartment of Pharmaceutical Analysis, C.L Baid Metha College of Pharmacy, Thoraipakkam, Chennai, 6000097, India. venista7@gmail.com.
Hemanth Kumar ChanduluruDepartment of Pharmaceutical Research, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai, 603203, India. hemanth.kumar361@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The ternary combination like omeprazole (OMP), amoxicillin (AMX), and rifabutin (RFB) was approved by the FDA in November 2019 for combating Helicobacter pylori infections and ulcers caused by this infection. This study aims to develop and authenticate a robust and eco-friendly RP-UPLC technique aimed at the concurrent analysis of OMP, AMX, and RFB, following ICH guidelines, Analytical Quality by Design (AQbD), and green analytical chemistry (GAC) principles. The analysis used the Thermo C18 column (100 mm × 2.1 mm, 1.7 µm), ethanol, and formic acid solution (43:57) as mobile phase with a flow rate of 0.2 ml/min at 272 nm. The method was developed based on the ICH Q14 and validated according to ICH Q2(R1) followed by Forced degradation studies under various conditions. The method showed good linearity for OMP, AMX, and RFB, with coefficient of determination (r2) of 0.9995, 0.9993, and 0.9997, respectively. Precision studies indicated low %RSD values, confirming high reproducibility. Forced degradation studies confirmed the stability of the drugs for 30 min in acid, base, and redox reactions, and they were also stable for 6 h at 105 °C in dry conditions. GAPI assessment depicted a green and yellow pictogram, AGREE scored 0.85, BAGI scored 80, and RGB12 Whiteness Assessment Tool scored 97.5%. The developed RP-UPLC-PDA technique is robust and reliable for the concurrent quantification of the triple combination. It aligns with sustainability goals, enhancing the efficiency and environmental sustainability of pharmaceutical analysis, and setting a benchmark for future analytical methods.

Indexed as

AmoxicillinAnalytical quality by designGreen analytical chemistryOmeprazoleRifabutinRP-UPLC

Identifiers

PMID39558405
PMCPMC11571561

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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.