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羟丙基-β-环糊精包合物中尼非韦罗含量测定和稳定性考察 预览

Determination of Nifeviroc and its stability in hydroxypropyl-β-cyclodextrin inclusion complex
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摘要 目的尼非韦罗是一种新型抗艾滋病药物,羟丙基-β-环糊精(hydroxypropyl-β-cyclodextrin,HP-β-CD)包合物增加尼非韦罗的水溶性和稳定性。文中采用反相高效液相色谱法测定环糊精包合物中尼非韦罗含量及考察其相关稳定性。方法采用GL Sciences Inertsil ODS柱(4.60×250 mm,5μm),检测波长265 nm,柱温30℃。以甲醇(A相)-复方醋酸缓冲液(B相,pH4.5)(65∶35,v/v)为洗脱流动相,采用等速度洗脱,流速为1 ml/min,采用外标法定量。结果尼非韦罗与各有关物质分离良好。在20.10~180.90μg/ml的浓度范围内,尼非韦罗峰面积与浓度具有良好线性关系(r=0.9999);重复性好[相对标准差(relative standard deviation,RSD)<1.5%];稳定性好(RSD<1.5%);加样回收率为100.5%(n=9)。结论此方法检测包合物中尼非韦罗含量操作简便、准确、灵敏度高、可靠。尼非韦罗经HP-β-CD包合后相关稳定性有明显提高。 Objective Nifeviroc is a novel anti-HIV drug,and the preparation of the Nifeviroc-hydroxypropyl-β-cyclodextrin inclusion complex would enhance water solubility and stability of the drug.This study aims to establish an HPLC method for the determination of Nifeviroc in cyclodextrin inclusion complex and to study the stability of Nifeviroc.Methods The separation was performed on a GL Science Inertsil ODS column(4.60×250 mm,5 μm) maintained at 30 ℃ and by a UV detector set at 265 nm.Methanol(phase A) compound acetic acid buffer(phase B)(60∶40,v∶v) was used as mobile phase to carry out isometric elution at a flow rate of 1.0ml/min,and content determination was used by the external standard method.Results Nifeviroc could be well separated from its related substances.A linear relationship was exhibited between the peak area and concentration of Nifeviroc at 20.10-180.90 μg/ml(r=0.999 9,with good repeatability(RSD<1.5%) and stability(RSD<1.5%).The average recovery rate was 100.5%(n=9).Conclusion This method is convenient,accurate,sensitive and reliable for determining the content of Nifeviroc in cyclodextrin inclusion complex.Hydroxypropyl-β-cyclodextrin inclusion complex can improve the stability of Nifeviroc.
作者 郝彬彬 王芹 任勇 王勇 吴稚伟 HAO Bin-bin1,WANG Qin1,REN Yong2,WANG Yong1,WU Zhi-wei1(1.Center for Public Health Research,School of Medicine of Nanjing University,Nanjing 210093,Jiangsu,China;2.Jiangsu Key Laboratory of Medical Supramolecular Materials and Their Application,Nanjing Normal University,Nanjing 210046,Jiangsu,China)
出处 《医学研究生学报》 CAS 2011年第6期 565-568,共4页 journal of Medical Postgraduate yixue yanjiusheng xuebao
基金 国家“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项“十一五”课题(2008ZX10001-015)
关键词 高效液相色谱法 羟丙基-Β-环糊精 尼非韦罗 含量 稳定性 High-performance liquid chromatography Hydroxypropyl-β-cyclodextrin Nifeviroc Content Stability
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