This research article describes stability indicating fast liquid chromatographic method for determination of chromatographic purity and assay of Nizatidine as a alternate for two different methods for chromatographic purity and assay as given in USP Monograph and Ph.Eur Monograph. Proposed method is developed on Waters symmetry RP18 (50 × 4.6 mm), 3.5 μm stationary phase using gradient elution with combination of Ammonium acetate Diethyl amine buffer, Methanol and Tetrahydrofuran as mobile phase. Favorable results are obtained under developed conditions, which guarantee good separation of studied components. Whereas, data obtained from method validation confirm specificity, high sensitivity, linearity in a range of studied concentrations, repeatability and good accuracy of this method. Considerable degradation observed in oxidation stress condition was detected by this method. Eight impurities are studied among which impurity-5 is found major degradant. The stress samples are assayed against a qualified standard and the mass balance is found close to 99.2%. The developed method can be used for routine samples as well as stability studies.
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机译:An economic evaluation of soil bioengineering as a method for slope stability on abandoned mine land in Eastern Kentucky <中文篇名〉=肯塔基州东部废矿斜坡稳定性的土壤生物工程 经济评估