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。
Objective： To develep a HPLC method for determining the content of voriconazole for injection and its related sulstances. Methods： ShimPack CLC-ODS C18 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.
出处
《药学进展》
CAS
2005年第12期562-565,共4页
Progress in Pharmaceutical Sciences
