HPLC梯度洗脱法测定伊曲康唑有关物质的方法研究

发布时间：2018-06-01 13:09

本文选题：伊曲康唑 + 有关物质　；参考：《中国抗生素杂志》2015年02期

【摘要】：目的建立高效液相色谱梯度洗脱法测定伊曲康唑的有关物质。方法采用反相高效液相色谱法,色谱柱为Alltech Hypersil BDS(100mm×4.6mm,3μm);以0.02mol/L硫酸氢四丁基铵溶液为流动相A,乙腈为流动相B,进行线性梯度洗脱;流速为1.5m L/min;检测波长为225nm。结果伊曲康唑及各已知杂质、中间体均能达到基线分离,样品中各杂质及主峰的分离度和检测灵敏度均满足有关物质的测定要求。结论方法灵敏、准确,专属性强,可用于测定伊曲康唑的有关物质。
[Abstract]:Objective to establish a gradient elution method for the determination of itraconazole by HPLC. Methods Reversed-phase high performance liquid chromatography (RP-HPLC) was used, the column was Alltech Hypersil BDS(100mm 脳 4.6 mm ~ (3) 渭 m ~ (-1), the mobile phase was 0.02mol/L H _ 2SO _ 4 _ 4 Ding Ji ammonium solution, and acetonitrile was used as mobile phase B, the flow rate was 1.5 mL / min and the detection wavelength was 225 nm. Results itraconazole and all known impurities and intermediates could achieve baseline separation. The separation degree and detection sensitivity of each impurity and main peak in the sample could meet the requirements of the determination of related substances. Conclusion the method is sensitive, accurate and specific. It can be used to determine the related substances of itraconazole.
【作者单位】：天津市药品检验所;
【基金】：《中华人民共和国药典》2010年版质量标准起草项目
【分类号】：R927.1;O657.72

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