摘要
目的：建立HPLC法测定阿米三嗪萝巴新片溶出度.方法：采用HPLC外标法测定阿米三嗪萝巴新片的溶出度.采用篮法,溶出介质为盐酸溶液（0.5→ 1000） 1000 mL,转速100 r·min-1,取样时间45 min.结果：阿米三嗪萝巴新片溶出度测定二甲磺酸阿米三嗪在1.5～3.6μg·mL-1浓度范围内呈线性（r=0.9999,n=5）,萝巴新0.5～1.2 μg·mL-1浓度范围内呈线性（r=0.9996,n=5）,回收率分别为98.2％、97.9％,RSD分别为53％、3.9％;样品溶出度均一性好,在45 min时2个组分溶出度均达到80％.结论：本法简便、准确、可行,可作为阿米三嗪萝巴新片的质量标准中控制项目之一.
Objective： To establish method for determination the dissolution of the Almitrine and Raubasine Tablets. Methods： The HPLC external standard method was applied to determine the dissolution of the Ahnitrine and Raubasine Tablets.Basket apparatus was used with hydrochloric acid（0.5---→1000）1000 mL as the dissolution medium at a speed of 100 r-min-I and dissolution time limit was 45 min. Results： The linear range of the Almitrine was 1.5-3.6 μg-mL-t and the correlation coefficient was 0.9999. The linear range of the Raubasine was 0.5-1.2 μg-mL-I and the correlation coefficient was 0.9996, The average recovery was 98.2 %, 97.9 %,, and the RSD was 5.3 %, 3.9 %. The dissolution of different batches of compound paraeetamol tablets fulfilled the requirements and had the similar nature Conclusion： The method is convenient, accurate and practicable. It can be applied to determine the dissolution of the tablets. Keywords： Almitrine and Raubasine Tablets： HPLC method; Content Determination
出处
《广东化工》
CAS
2013年第23期173-173,176,共2页
Guangdong Chemical Industry
基金
重大新药创制"科技重大专项:特殊环境军队特需药品上药集团产学研联盟建设(项目编号:2011ZXJ09301)
关键词
阿米三嗪萝巴新片
HPLC法
有关物质
Almitrine and Raubasine Tablets： HPLC method
Content Determination
