Evidence mapPaperPMID 42010702Full record

ArticleBMC chemistry2026

Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of dapagliflozin and eplerenone in bulk and synthetic mixture.

Prexa Tandel, Hiralben Mehta

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Article in BMC chemistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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4 · The record

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5 · Who and what money

Authors and funding

2 authors.

Prexa TandelDepartment of Quality Assurance, Parul Institute of Pharmacy and Research, Parul University Limda, Vadodara, Gujarat, 391760, India.
Hiralben MehtaDepartment of Quality Assurance, Parul Institute of Pharmacy and Research, Parul University Limda, Vadodara, Gujarat, 391760, India. hiralben.mehta29533@paruluniversity.ac.in.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A stability-indicating analytical method utilizing reverse-phase high-performance liquid chromatography was developed and validated for the simultaneous quantification of dapagliflozin and eplerenone in bulk drug materials and a laboratory-prepared synthetic mixture. Chromatographic separation was achieved on a Shim-pack C18 column (250 × 4.6 mm, 5 μm) using an isocratic elution of methanol and water (80:20, v/v) at a constant flow rate of 1.0 mL/min. Detection was carried out with a photodiode array detector set at 265 nm. The method exhibited a linear response across concentration ranges of 1-5 µg/mL for dapagliflozin and 2.5-12.5 µg/mL for eplerenone, with correlation coefficients exceeding 0.999. Validation studies, conducted in accordance with the International Council for Harmonization (ICH-International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Q2(R2) guidelines, confirmed that the method was precise, accurate, robust, specific, and sensitive. The stability-indicating capability was verified through forced degradation experiments under acidic, alkaline, oxidative, thermal, and photolytic stress conditions, where degradation products were adequately resolved from the parent compounds using the developed method. The validated method was successfully applied to the analysis of a synthetic mixture, yielding assay results of 99.56% for dapagliflozin and 99.48% for eplerenone. Therefore, the proposed method is suitable for routine quality control analysis and stability studies.

Indexed as

DapagliflozinEplerenoneStability-indicating RP-HPLCSynthetic mixture

Identifiers

PMID42010702
PMCPMC13235065

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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 Socratic graph.