Abstract
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.
Highlights
IntroductionNizatidine is a histamine H2-receptor antagonist that inhibits stomach acid production, and commonly used in the treatment of peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD)
Nizatidine is a histamine H2-receptor antagonist that inhibits stomach acid production, and commonly used in the treatment of peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). It was developed by Eli Lilly and is marketed under the trade names Tazac and Axid Certain preparations of Nizatidine are available over the counter in various countries including the United States
In the literature survey there is no fast LC stability indicative methods are reported for chromatographic purity and assay for Nizatidine
Summary
Nizatidine is a histamine H2-receptor antagonist that inhibits stomach acid production, and commonly used in the treatment of peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). It was developed by Eli Lilly and is marketed under the trade names Tazac and Axid Certain preparations of Nizatidine are available over the counter in various countries including the United States. USP monograph describes a chromatographic purity method with a runtime of 70 minutes and separate assay method with a runtime of 40 minutes. Validation of chromatographic purity and assay determination methods for accurate quantification of eight impurities and in Nizatidine samples along with assay determination is described in this paper is carried out as per ICH recommendations. Intensive stress studies were carried out for possible degradants identification and degradation pathway is established for Nizatidine with validated proposed method
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