HPLC测定氟他胺有关物质
崔正华
【期刊名称】《食品与药品》 【年(卷),期】2013(015)003
【摘要】目的 建立高效液相色谱法(HPLC)测定氟他胺中有关物质的含量.方法 采用HPLC,用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);流动相:甲醇-水(60∶40);检测波长:230 nm;进样量:20 μL;流速:1.0 mL/min;柱温:25℃.结果 氟他胺与各杂质能得到有效分离,各杂质在0.04~2.0 μg/mL范围内线性良好.结论 本测定方法操作方便,灵敏度高,准确可靠,可用于氟他胺中有关物质的测定.%Objective To establish an HPLC for determination of related substances in flutamide.Methods The chromatographic procedure was carried out with Diamonsil C18 (250 mm × 4.6 mm,5 μm) as an analytical column and methanol-water (60∶40) as mobile phase at a flow rate of 1.0 mL/min.The detection wavelength was 230 nm and the column temperature was 25 ℃.Results Flutamide could be completely separated from the other impurities with a linear range of 0.04~2.0 μg/mL.Conclusion A sensitive and accurate method for determination of related substances in flutamide was established. 【总页数】2页(191-192)
【关键词】氟他胺;高效液相色谱法;有关物质 【作者】崔正华
【作者单位】山东大学药学院,山东济南250012