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青蒿琥脂片溶出度测定的方法学验证

         

摘要

Objective To methodologically validate the detection of solubility of artesunate tablets. Methods The de-tection was carried out following the procedure described in the second method in appendix ⅩC,second part of 2010 edition of Chinese Pharmacopoeia. The solubility of artesunate tablets was detected with ultraviolet spectrophotometry at 289 nm. According to the results,it was validated a methodology. Results By using this method the artesunate tablets srtesunate tablets was determined, respectively in pH1.2, 4.5, 6.8, water four dissolution medium, a linear regression analysis was performed by using the concentration and UV absorption as independent and dependent variables respec-tively. Within the concentration range of 10μg/mL to 60μg/mL,excellent linear relevance was witnessed between con-centration and absorption. In the above four kinds of dissolution medium average recovery and standard deviation were conformed to the requirements. Concluslon The dissolubility determination artesunate tablets method could be used for the quality control of products.%目的:对青蒿琥脂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[1]。采用紫外分光光度法,在289 nm的波长处测定吸光度,进行方法学验证。结果采用该方法测定青蒿琥脂片,分别在pH1.2、4.5、6.8、水四种溶出介质中,以浓度对吸收度进行线性回归,青蒿琥酯在10~60μg/mL范围内浓度与吸收度呈良好的线性关系。在以上四种溶出介质中的平均回收率和标准偏差均符合要求。结论本法测定青蒿琥酯片溶出量方法尚可,可用于该产品的质量控制。

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