文档介绍：阿莫西林克拉维酸钾分散片的质量标准研究
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【摘要】目的:建立简便快捷的阿莫西林克拉维酸钾分散片中阿莫西林和克拉维酸有关物质的HPLC测定方法。方法:采用BDS HYPERSIL C18色谱柱(×250mm,5μm),·L-1磷酸二氢钠溶液(用10%)-甲醇(95:5),检测波长为220nm, mL·min-1,进样量为20μL,柱温为25℃。结果:此条件下,阿莫西林克拉维酸钾分散片中各杂质和其他降解产物与主成分的分离度和检测灵敏度均可满足试验要求。结论:采用HPLC测定阿莫西林克拉维酸钾分散片中阿莫西林和克拉维酸的有关物质,方法简便、结果准确可靠,适用于该制剂的质量控制。
【关键词】阿莫西林克棒酸钾合剂;色谱法/高压液相;质量控制
【ABSTRACT】Objective:To build a more convenient way for detecting related substances of high performance liquid chromatography and Clavulanate Potassium dispersible :The separation was performed on BDS HYPERSIL C18 column(
×250mm,5μm),setting a mobile phase of ·L-1 sodium dihydrogen phosphate(adjusted to pH with 10% phosphoric acid or sodium hydroxide test solution)- methanol(95∶5),and the detected wavelength was 220mm,velocity was ·min-1 and injection volume was 20μL with the column temperature 25℃.Results:Under this condition,Amoxicillin and Clavulanate Potassium dispersible tablets in various impurities,other degradation products,ponent of separation and the detection sensitivity could satisfy test :The method developed is essfully used to determine Amoxicillin and Clavulanate Potassium dispersible tablets related substances,so it can be used for quality control of Danhuang Tablets.
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