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  • Author or Editor: Ebtesam S. Mahmoud x
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Two chromatographic methods were developed for the simultaneous determination of paracetamol, pamabrom, and pyrilamine maleate in bulk and combined pharmaceutical dosage form. The first method is an ultra-performance liquid chromatographic (UPLC) method, in which separation was carried out by gradient elution using C18 column and a mobile phase composed of solution A (acetonitrile) and solution B (phosphate buffer) (pH 3.5). The elution started with 20% (by volume) acetonitrile ramped up linearly to 100% in 2 min, then kept constant till the end of the run at a flow rate of 1.5 mL min−1 and ultraviolet (UV) detection at 277 nm. The second method depends on the densitometric determination of thin-layer chromatograms of the three drugs. Separation was carried out at 275 nm using chloroform‒acetonitrile (15:35, v/v) as the mobile phase. The proposed methods were validated according to the International Conference on Harmonisation (ICH) guidelines. Beer’s law was obeyed in the range of 5–100 μg mL−1 for paracetamol and 0.5–20 μg mL−1 for pamabrom and pyrilamine maleate, respectively, with mean recoveries of 98.40‒100.32% ± 0.551‒0.771 for the UPLC method. Linearity of the thin-layer chromatographic method was achieved in the range of 10‒280, 5‒45, and 1–20 ng per spot of the three drugs with mean recoveries of 98.75‒100.30% ± 0.971‒1.061, respectively. The two methods were successfully applied for the simultaneous determination of the cited drugs in their laboratory-prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The results obtained were compared with those of the reported method and found to be in good agreement.

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