抗艾滋病药物F18和尼非韦罗在Solutol HS15形成复合制剂后的高效液相色谱测定

HPLC analysis of anti-HIV drugs F18 and nifeviroc in Solutol HS 15

目的:解决F18和尼非韦罗二者水溶性差的问题,并建立F18和尼非韦罗两种药物混合物的高效液相色谱(HPLC)检测条件。方法:采用GL Sciences Inertsil ODS柱(4.60 mm×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-1。结果:Solutol HS15能够很好地溶解F18和尼非韦罗,二者的出峰时间分别为34.3和14.2 min,最小检测限1μg.ml-1,20～180μg.ml-1的线性关系良好。结论:本研究所建立的分析检测条件为后续的研究提供有效的检测和分析手段,为以后的阴道杀微生物剂稳定制剂及联合用药奠定了基础。

Objective： To describe the studies for the analysis of F18 and nifeviroc mixture and the development of a HPLC-based quantitative method which use Solutol HS15 as solubilizer.Methods： The separation was performed on a GL Science Inertsil ODS column（4.60 mm×250 mm,5 μm） maintained at 30 ℃ and monitored by an UV detector at 265 nm.Methanol（phase A） and acetic acid buffer（phase B）（65 ∶35,V/V） was used as mobile phase to carry out isometric elution at a flow rate of 1.0 ml·min-1.Results： Nifeviroc and F18 were well separated from each other in Solutol HS15 under the conditions,with distinct peaks at 34.3 and 14.2 min,respectively.The recovery of both components were quantitative and the linear range for F18 was from 20 to 180 μg·ml-1 with r=0.997 6,and for nifeviroc was from 20 to 180 μg·ml-1 with r=0.999 1.Conclusion： The HPLC conditions established in this study allows accurate,sensitive and reproducible detection of both components,with sufficient dynamic ranges.