【摘要】 目的建立测定注射用伏立康唑含量及有关物质的HPLC法。方法采用ShimPack CLC-ODS C18色谱柱(4.6mm×150mm,5μm),流动相为0.04mol/L磷酸二氢铵溶液(用氨水调节pH值至6.0)-乙腈(50∶50),流速为1.0mL/min,检测波长为256nm,进样量为20μL。结果伏立康唑与杂质分离良好,在0.015～0.15g/L范围内伏立康唑浓度与峰面积呈良好线性关系(r=0.9999),日内和日间RSD均小于1.5%,最低检测量为0.5ng,最低定量限为1.5ng。样品中有关物质检查符合要求。结论该法简便、快速、专属性强,可用于注射用伏立康唑含量及有关物质的测定。更多还原

【Abstract】 Objective: To develep a HPLC method for determining the content of voriconazole for injection and its related sulstances. Methods: ShimPack CLC-ODS C_ 18 Column (4.6 mm×150 mm,5 μm) and 0.04 mol/L ammonium dihydrogen phosphate solution (adjusted to pH 6.0)-acetonitrile (50∶50)as mobile phase were used with a flow rate of 1.0 mL/min, a detection wavelength of 256 nm and a injection volume of 20 μL. Results: A satisfactory seperation was obtained between voriconazole and related substances. The calibration curve was linear in the range of 0.015～0.15 g/L for voriconazole with good correlation coefficient (r=0.9999). The RSDs of intra-and inter-day were both less than 1.5%,the detection limit was 0.5 ng and the quantitative limit was 1.5 ng. The examining result of related substances in sample conformed to quality requirement. Conclusion:The HPLC assay is simple and quick with high specificity,and can be used for the determination of voriconazole for injection and its related substances.更多还原