Category: ethers-buliding-blocks. The reaction of aromatic heterocyclic molecules with protons is called protonation. Aromatic heterocycles are more basic than benzene due to the participation of heteroatoms. Compound: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole, is researched, Molecular C17H19N3O2S, CAS is 73590-85-9, about A validated stability indicating ultra performance liquid chromatographic method for determination of impurities in Esomeprazole magnesium gastro resistant tablets. Author is Nalwade, Santaji Uttam; Reddy, Vangala Ranga; Rao, Dantu Durga; Morisetti, Nagendra kumar.
A novel gradient reversed-phase ultra performance liquid chromatog. method has been developed for quant. determination of Esomeprazole magnesium and its seven impurities in pharmaceutical dosage forms. Chromatog. separation has been achieved on an Acquity BEH C18, 50 mm × 2.1 mm, 1.7 μm with buffered mobile phase consisting solvent A (0.04 M (M) glycine (pH 9.0) buffer) and solvent B (mixture of acetonitrile and Milli-Q water in the ratio 90: 10 (volume/volume); resp.) delivered at flow rate of 0.21 mL min-1 and the detection wavelength 305 nm. Resolution of Esomeprazole magnesium and all the seven potential impurities has been achieved greater than 2.0 for all pairs of compounds The drug was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation Esomeprazole magnesium was found to degrade significantly in oxidative and acid hydrolysis stress conditions and stable in base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, thus proved the stability indicating power of the method. The stress samples were assayed against a reference standard and the mass balance was found to be close to 99.1%. So this method was also suitable for Assay determination of Esomeprazole magnesium in pharmaceutical dosage forms. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.
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Reference:
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Ether | (C2H5)2O – PubChem