Selective quantitation of co-formulated ternary mixture in the presence of potential impurities by liquid chromatographic methods

Fayed, Ahmed S.; Boltia, Shereen A.; Musaed, Awadh; Hegazy, Maha A.

doi:10.1016/j.jpba.2019.112821

Cited by 5 publications

(1 citation statement)

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“…Chromatographic techniques have the potential to meet the global drifts toward sustainable chemistry at all stages of the investigation, starting from collection and preparation of samples to separation and final determination (Płotka et al, 2013). These techniques are a well‐accepted and multi‐purpose approach in the pharmaceutical industry for the quantitation of drugs as well as for impurity profiling applications (Fayed, Boltia, Musaed, & Hegazy, 2020; Ferenczi‐Fodor, Végh, & Renger, 2011).…”

Section: Introductionmentioning

confidence: 99%

Greenness profile assessment of selective liquid chromatographic methods for determination of a quaternary antimigraine combination along with three of their related official impurities

Marzouk

Ibrahim

Hegazy

et al. 2021

Biomedical Chromatography

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Two selective, sensitive and environmentally safe LC methods were developed and validated for determination of paracetamol, caffeine, ergotamine tartrate and metoclopramide in coformulated antimigraine tablets along with p‐aminophenol, p‐nitrophenol and theophylline as officially specified impurities. The first is based on high‐performance thin‐layer chromatography (HPTLC) coupled with densitometric quantitation. Separation was achieved on HPTLC silica gel 60 F254 plates as stationary phase using ethyl acetate:aqueous ammonium hydroxide solution:glacial acetic acid (10.0:0.4:0.1, by volume) as a developing system followed by scanning of the separated bands at 210.0 nm. The subsequent method depends on HPLC with diode array detection. The LC separation was accomplished on a Scharlau C18 (250 × 4.6 mm, 5 μm) column using a mixture of 20.0 mm sodium dihydrogen phosphate, pH 3.0, adjusted with o‐phosphoric acid and methanol, at a flow rate of 1.3 mL/min in a gradient elution program. The separated peaks were detected at 210.0 nm. The proposed methods have been validated and proven to meet the requirements outlined in the International Council for Harmonisation (ICH) guidelines. The greenness profile evaluation was carried out using three tools, namely, the National Environmental Method Index, the Analytical EcoScale and the Green Analytical Procedure Index tool, and a comparative study was then conducted. Successful application of the developed methods for determination of the cited quaternary mixture in Metograine tablets confirms their suitability regarding the analytical performance and ecological impact in quality control assay and impurity profiling purposes.

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Section: Introductionmentioning

confidence: 99%