阿司匹林泡腾片中有关物质及其含量测定方法研究

A Study on the Determination Methods of Related Substances and Content in Aspirin Effervescent Tablets

目的研究阿司匹林泡腾片中辅料对有关物质检测及其含量测量方法的影响。方法参考中国药典2010年版二部收录的阿司匹林泡腾片高效液相色谱法,通过空白辅料的干扰实验、线性关系、精密度、溶液稳定性、重现性、回收率等方法对阿司匹林泡腾片的药品质量标准分析方法进行验证。结果空白辅料对阿司匹林泡腾片的有关物质和含量测定无影响,线性关系、精密度、溶液稳定性、重现性、回收率都符合规定。结论中国药典2010年版的检验方法可行,辅料对有关物质检查方法及含量测定方法没有影响。

Objective Tartaric acid,amylum pregelatinisatum,saccharin sodium,Lactis Anhydrous,starch,sodium bicarbonate,Gum Arabic and other materials can be found in Aspirin Effervescent Tablets.In the routine testing,it is easy to impact its content because of the presence of these substances.The impact of accessories on related substances in this product and content were probed into by referring to HPLC of aspirin effervescent tablets in the 2010 edition of Chinese Pharmacopoeia.Methods The analyzing methods of drug quality standard of Aspirin Effervescent Tablets were verified through the way of blank materials interference test,linear relationship,precision,solution stability,reproducibility,recovery rate,etc.Results The blank accessories had no effects on the determination of related substances and content,and linear relationship,precision,solution stability,reproducibility,recovery rate,etc.were in line with the requirements.Conclusion The testing methods in the 2010 edition of China Pharmacopoeia are feasible and accessory materials had no effect on the testing methods of related substances and content determination.