| 高效液相色谱-梯度洗脱法测定恩替卡韦分散片的含量和有关物质 |
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| 引用本文： | 冀满丰. 高效液相色谱-梯度洗脱法测定恩替卡韦分散片的含量和有关物质[J]. 中国药业, 2012, 21(9): 26-27 |
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| 作者姓名： | 冀满丰 |
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| 作者单位： | 广东省深圳市宝安区龙华人民医院,广东深圳,518109 |
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| 摘 要： | 目的 建立测定恩替卡韦分散片含量及其有关物质的高效液相色谱-梯度洗脱法.方法 色谱柱为Kromasil C18柱(250mm×4.6mm,5μm),流动相以乙腈-水梯度洗脱,检测波长为254 nm,流速为1 mL/min,柱温为30℃,进样量为20μL.结果 恩替卡韦进样量线性范围为1.001～6.006μg(r=0.999 5),平均回收率为100.00%(RSD=0.05%).结论 该方法简便、准确、专属性强,可用于该制剂的质量控制.
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| 关 键 词： | 梯度洗脱法 恩替卡韦分散片 含量 有关物质 |
Content Determination of Entecavir Dispersible Tablets and Its Related Substances by Gradient Elution |
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| Ji Manfeng. Content Determination of Entecavir Dispersible Tablets and Its Related Substances by Gradient Elution[J]. China Pharmaceuticals, 2012, 21(9): 26-27 |
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| Authors: | Ji Manfeng |
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| Affiliation: | Ji Manfeng(Longhua People’s hospital of Baoan District,Shenzhen,Guangdong,China 51810 9) |
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| Abstract: | Objective To establish a method for the determination of Entecavir Di spersible Tablets and its related substances.Methods HPLC-gradient elution was performed on Kromasil C18 column(250 mm×4.6 mm,5 μm) using acetonitrile-wate r as the mobile phase at a flow rate of 1 mL/min.The detection wavelength was at 254 nm.The column temperature was 30 ℃and the sample size was 20 μL.Results The linear range of entecavir was 1.001-6.006 μg(r=0.999 5),the average recov ery was 100.00%(RSD=0.05%).Conclusion The method is simple,accurate,special and can be used for the quality control of Entecavir Dispersible Tablets. |
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| Keywords: | gradient elution Entecavir Dispersible Tablets content related subst ances |
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