| HPLC法测定阿德福韦酯片的含量和有关物质 |
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| 引用本文： | 左燕,;吕卓,;董建平,;翟绍晶. HPLC法测定阿德福韦酯片的含量和有关物质[J]. 西北药学杂志, 2014, 0(5): 469-471 |
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| 作者姓名： | 左燕, 吕卓, 董建平, 翟绍晶 |
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| 作者单位： | [1]陕西省人民医院,西安710068; [2]陕西省食品药品检验所,西安710075; [3]陕西天森药物研究开发有限公司,西安710075 |
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| 摘 要： | 目的建立高效液相色谱法测定阿德福韦酯片的含量和有关物质。方法采用Hypersil C18色谱柱,以乙腈-水(45∶55)(用磷酸调pH=4.0)为流动相,检测波长为261nm,流速为1.0mL·min-1。结果阿德福韦酯质量浓度在1.03662.161μg·mL-1范围内线性关系良好(r=0.999 8),最低检测限为0.24ng,回收率为100.6%。结论该方法准确,灵敏,精密度高,专属性强,可用于阿德福韦酯片的含量测定和有关物质检查。
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| 关 键 词： | 阿德福韦酯片 含量测定 有关物质 高效液相色谱法 |
Determination of Adefovir Dipivoxil Tablets and related substances by HPLC |
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| Affiliation: | ZUO Yan, LU Zhuo , DONG Jianping , ZHAI Shaojing (1. Shaanxi Provincial People＇s Hospital, Xi＇an 710068, China; 2. Shaanxi Institute for Food and Drug Control, Xi＇an 710075 ,China; 3. Shaanxi Tiansen Pharmaceutical Liminted Company, Xi＇an 710075, China) |
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| Abstract: | Objective To establish an HPLC method for the determination of Adefovir Dipivoxil Tablets and its related substances . Method The analytical column was Hypersil C18 and the mobile phase was acetonitrile-water （45∶55） adjusted with phosphoric acid to a pH of 4 .0 .The detection wavelength was 261 nm and the flow rate was 1 .0 mL · min-1 .Results Adefovir dipivoxil was linear in the range from 1 .036 to 62 .161 μg · mL -1 （r=0 .999 8） .The limit of detection was 0 .24 ng and the average recovery was 100 .6% .Conclusion The method was accurate ,sensitive ,precise ,and can be used for the content assay ,as well as the analysis of the related substances in Adefovir Dipivoxil Tablets . |
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| Keywords: | Adefovir Dipivoxil Tablets content determination related substances HPLC |
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