title: A validated stability indicating ultra performance liquid chromatographic method for determination of impurities in Esomeprazole magnesium gastro resistant tablets.
abstract: 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.
authors.affiliation: Dr. Reddy's Laboratories Ltd. IPDO, Bachupally, Hyderabad 500090, A.P., India. santajin@rediffmail.com
authors.forename: Santaji Uttam
authors.initials: SU
authors.lastname: Nalwade
authors.forename: Vangala Ranga
authors.initials: VR
authors.lastname: Reddy
authors.forename: Dantu Durga
authors.initials: DD
authors.lastname: Rao
authors.forename: Nagendra Kumar
authors.initials: NK
authors.lastname: Morisetti
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D064098:Esomeprazole / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D013055:Spectrophotometry, Infrared; D013607:Tablets
chemical_list: D013607:Tablets; D064098:Esomeprazole