Premium
Greenness profile assessment of selective liquid chromatographic methods for determination of a quaternary antimigraine combination along with three of their related official impurities
Author(s) -
Marzouk Hoda M.,
Ibrahim Engy A.,
Hegazy Maha A.,
Saad Samah S.
Publication year - 2021
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.5132
Subject(s) - chemistry , chromatography , phosphoric acid , ammonium acetate , acetic acid , high performance liquid chromatography , ammonium hydroxide , sodium hydroxide , organic chemistry , biochemistry
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 F 254 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 C 18 (250 × 4.6 mm, 5 μm) column using a mixture of 20.0 m m 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.