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阿哌沙班片溶出度测定方法研究
引用本文:郭兆元,聂忠莉,胡一冰,曾吉,王晓玲,叶丁,张勇,萧茂玲,郭瑞.阿哌沙班片溶出度测定方法研究[J].成都大学学报(自然科学版),2016,35(4).
作者姓名:郭兆元  聂忠莉  胡一冰  曾吉  王晓玲  叶丁  张勇  萧茂玲  郭瑞
作者单位:成都大学四川抗生素工业研究所,四川成都,610052;成都大学药学与生物工程学院,四川成都,610106;成都克莱蒙医药科技有限公司,四川成都,610041
摘    要:建立了以高效液相色填充谱法测定阿哌沙班片溶出度的测定方法,采用0.1%CTAB-pH 6.8的磷酸盐缓冲溶液900mL为溶出介质,温度为37℃±0.5℃,转速为75r/min,溶出介质经脱气处理,取样时间为30min.结果显示,6批供试品及对照药品30min的溶出度均在80%以上,均符合规定.方法专属性强,灵敏度高,结果准确,可用于测定阿哌沙班片的溶出度.

关 键 词:阿哌沙班片  溶出度  高效液相色谱法

Study on Dissolution Determination Method of Apixaban
GUO Zhaoyuan,NIE Zhongli,HU Yibing,ZENG Ji,WANG Xiaoling,YE Ding,ZHANG Yong,XIAO Maoling,GUO Rui.Study on Dissolution Determination Method of Apixaban[J].Journal of Chengdu University (Natural Science),2016,35(4).
Authors:GUO Zhaoyuan  NIE Zhongli  HU Yibing  ZENG Ji  WANG Xiaoling  YE Ding  ZHANG Yong  XIAO Maoling  GUO Rui
Abstract:The paper is going to establish a method of dissolution determination of Apixaban .The establish-ment of the determination method for dissolution of Apixaban tablets is based on High Performance Liquid Chromatography .Phosphate buffer solution of 0.1% CTAB-pH 6.8 is used as dissolution medium which is degassed at 37 ± 0.5 ℃ ,with the rotate speed of 75 r/min and the sampling time of 30 min .The results show that the dissolution of six batches of test samples and reference drug is over 80% in 30 min .It is in compliance with the regulations .The method can be used to determine the dissolution of Apixaban tablets with its selective ,sensitive and accurate traits .
Keywords:Apixaban tablets  dissolution  High Performance Liquid Chromatography (HPLC)
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