A validated stability indicating ultra performance liquid chromatographic method for determination of impurities in Esomeprazole magnesium gastro resistant tablets
Autor: | Santaji Nalwade, Dantu Durga Rao, Vangala Ranga Reddy, Nagendra kumar Morisetti |
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Rok vydání: | 2012 |
Předmět: |
Detection limit
Esomeprazole Magnesium Magnetic Resonance Spectroscopy Chromatography Spectrophotometry Infrared medicine.diagnostic_test Chemistry Clinical Biochemistry Pharmaceutical Science Esomeprazole High-performance liquid chromatography Mass Spectrometry Dosage form Analytical Chemistry Solvent Hydrolysis Drug Stability Spectrophotometry Drug Discovery medicine Acid hydrolysis Chromatography High Pressure Liquid Spectroscopy Tablets |
Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 57:109-114 |
ISSN: | 0731-7085 |
Popis: | A novel gradient reversed-phase ultra performance liquid chromatographic method has been developed for quantitative determination of Esomeprazole magnesium and its seven impurities in pharmaceutical dosage forms. Chromatographic separation has been achieved on an Acquity BEH C18, 50mm×2.1mm, 1.7μm with buffered mobile phase consisting solvent A (0.04molar (M) glycine (pH 9.0) buffer) and solvent B (mixture of acetonitrile and Milli-Q water in the ratio 90: 10 (v/v); respectively) delivered at flow rate of 0.21mL min(-1) and the detection wavelength 305nm. 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. |
Databáze: | OpenAIRE |
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