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标题是：Stress Degradation Studies on Aripiprazole and Development of a Validated Stability Indicating LC Method 内容是： The present paper describes the development of a stability indicating reversed phase column liquid chromatographic method for aripiprazole in the presence of its impurities and deg- radation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of aqueous hydrolysis, oxidative, photolytic and thermal stress degradation. The degradation of aripiprazole was observed under acid hydrolysis and peroxide. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from the synthetic impurities and degradation products formed under stress conditions was achieved on an Inertsil phenyl column using a mixture of 0.2% triflu- oroacetic acid and acetonitrile (55:45, v/v). The developed LC method was validated with respect to linearity, accuracy, precision, specificity and robustness. The assay method was found linear in the range of 25–200 lgmL -1 with a correlation coefficient of 0.9999 and the linearity of the impurities were established from LOQ to 0.3%. Recoveries of the assay and impurities were found between 97.2 and 104.6%. The developed LC method for the related substances and assay determination of aripiprazole can be used to evaluate the quality of regular production samples. It can also be used to test the stability samples of aripiprazole. To the best of our knowledge, the validated stability indicating LC method which separates all the impurities disclosed in this investigation was not published elsewhere. |
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ringzhu(金币+2):哈哈~~偶也觉得他那句话说的很不错 可以拿来放在版规里边~~ 2010-12-16 10:29:57
ringzhu(金币+2):哈哈~~偶也觉得他那句话说的很不错 可以拿来放在版规里边~~ 2010-12-16 10:29:57
| 唉……楼主应该自强不息啊，做学问的，基本上英文都问题不大，实在不行，也可以翻着字典一点一点来。论坛上有求助翻译的也就一小段或者几句话，或者是自己根本不掌握的语种……楼主这种情况，实在应该反省自身。——————————————————————————————————————转自pulllantern 金虫 原帖见https://muchong.com/bbs/viewthread.php?tid=2676686&fpage=1 |
5楼2010-12-14 20:44:06
