盐酸阿莫地喹片溶出度测定的方法学研究

摘要

OBJECTIVE To validated the methodology detection of solubility of Amodiaquine Hydrochloride Tablets.METHODS The detection was carried out following the procedure described in the second method in ap-pendix ⅩC,second part of 2010 edition of Chinese Pharmacopoeia.The solubility of Artesunate Tablets was detected with ultraviolet spectrophotometry at 342nm.According to the results ,we validated it methodology.RESULTS The determination of Amodiaquine Hydrochloride Tablets was carried out by using this method ,respectively in pH 1.2, 4.5 ,6.8 ,four water dissolution medium ,we performed a linear regression analysis by using the concentration and UV absorption as independent and dependent variables respectively.Within the concentration range of 4~25μg· mL-1 , excellent linear relevance was witnessed between concentration and absorption.In the above four kinds of dissolution medium average recovery and standard deviation were conform to the requirements.CONCLUSION The dissolubil-ity determination Amodiaquine Hydrochloride Tablets method can be used for the quality control of products .%目的：对盐酸阿莫地喹片的溶出度检查进行方法学验证。方法参照《中国药典》2010年版二部附录ⅩC第二法对其溶出度进行检查。采用紫外分光光度法，在342 nm的波长处测定吸光度，进行了方法学验证。结果采用该方法测定盐酸阿莫地喹片，分别在pH 1.2、4.5、6.8的缓冲溶出介质及水4种溶出介质中，以浓度对吸收度进行线性回归，盐酸阿莫地喹在4～25μg · mL -1范围内浓度与吸收度呈良好的线性关系。在以上4种溶出介质中的平均回收率和标准偏差均符合要求。结论本法测定盐酸阿莫地喹片溶出量方法可行，可用于该产品的质量控制。