| 盐酸多西环素片有关物质测定方法的讨论 |
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| 引用本文： | 马仕洪,武秀娟,胡昌勤.盐酸多西环素片有关物质测定方法的讨论[J].中国药品标准,2004,5(6):54-57. |
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| 作者姓名： | 马仕洪 武秀娟 胡昌勤 |
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| 作者单位： | 中国药品生物制品检定所,北京,100050 |
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| 摘 要： | 目的:讨论中国药典盐酸多西环素片有关物质测定方法的合理性.方法:以一批盐酸多西环素片为例,通过改变色谱条件,分别测定盐酸多西环素片中有关物质的含量,比较结果的异同,并分析原因.结果:同一批样品,在中国药典允许的调整范围内改变色谱条件,可以得出截然不同的结论,通过HPLC-PDA分析,发现是由于样品中有一未知杂质,按现行中国药典方法未得到分离,而依据现行判定方法造成误判所致.结论:中国药典盐酸多西环素片有关物质测定方法有待完善.
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| 关 键 词： | 盐酸多西环素片 有关物质 方法讨论 |
Discussion on Determination Method of Related Substances in Doxycycline Hyclate Tablets |
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| Authors: | Ma Shihong Wu Xiujuan and Hu Changqin |
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| Institution: | National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050;National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050;National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050 |
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| Abstract: | Objective: To discuss the determination method of related substances in Doxycycline Hyclate Tablets in Chinese Pharmacopoeia(for short CP).Methods: We assayed the related substances in the same sample by different HPLC conditions, and analysed the results.Results: We tested the same sample by different HPLC conditions of the CP permissibly and acquired different results.We found an unknown impurity in this sample by HPLC-PDA.The unknown impurity wasn''t separated by the current method of CP,and just the unknown impurity made a mistaken sentence.Conclusions: The determination method of related substances in Doxycycline Hyclate Tablets of CP should be improved in the future. |
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| Keywords: | Doxycycline Hyclate Tablets Related Substances Discussion |
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