Dinesh Dhamecha, Kiran Jadhav, Shyam Ghadlinge, S. Shelke, Ritesh Fule
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引用次数: 2
摘要
背景:建立了一种简便、选择性好、准确度高、稳定性好的高效薄层色谱分析方法，并对该方法进行了验证。材料与方法:以氯仿:乙醇:乙酸(8:1:1)为流动相，在60f254铝背硅胶板上对化合物进行分析。在230 nm处进行拉弗丁的密度分析。结果:校正图的回归分析数据表明，在100-500 ng /点范围内，响应与浓度之间具有良好的线性关系。相关系数(r2)为0.998±0.002。结论:拉弗丁具有酸、碱、过氧化和日光降解作用。在稳定性试验中，该药物易受酸碱水解、氧化和光降解。
Development and validation of a stability indicating HPTLC-densitometric method for lafutidine
Background: A simple, selective, precise, and stability indicating high-performance thin layer chromatographic method has been established and validated for analysis of lafutidine in bulk drug and formulations. Materials and Methods: The compounds were analyzed on aluminum backed silica gel 60 F 254 plates with chloroform:ethanol:acetic Acid (8:1:1) as mobile phase. Densitometric analysis of lafutidine was performed at 230 nm. Result : Regression analysis data for the calibration plots were indicative of good linear relationship between response and concentration over the range 100-500 ng per spot. The correlation coefficient (r 2 ) was 0.998±0.002. Conclusion: Lafutidine was subjected to acid, base, peroxide, and sunlight degradation. In stability tests, the drug was susceptible to acid and basic hydrolysis, oxidation, and photodegradation.
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