用反相高效液相色谱法同时测定复方酮康唑软膏中三组分的含量

目的建立同时测定复方酮康唑软膏中酮康唑、莫匹罗星和糠酸莫米松含量的方法。方法采用反相高效液相色谱法,色谱柱为Intersil ODS-3(250 mm×4.6 mm,5μm),流动相为甲醇-pH5.5磷酸盐缓冲液(65∶35),柱温45℃,流速1.0 ml/min,检测波长248 nm。结果方法学验证表明,酮康唑、莫匹罗星和糠酸莫米松3种成分线性关系良好(r≥0.9995),日内日间精密度均小于3.0%,回收率在90%~108%之间,稳定性和重复性的RSD均小于3.0%,符合方法学要求。按照新建立的方法测定了3个批次样品中三组分的含量,结果符合要求。结论该方法简便可靠,可为复方酮康唑软膏的质量控制提供依据,也为其质量标准研究奠定了基础。

Determination of three constituents in compound ketoconazole ointment by RP-HPLC

Objective To establish a RP-HPLC method for determination of ketoconazole,mupirocin and mometasone furoate in compound ketoconazole ointment.Methods RP-HPLC was conducted on a Intersil ODS-3 column(250 mm×4.6 mm,5μm),with methanol-PBS with pH 5.5(65:35)as the mobile phase and the column temperature was 45℃.The flow rate was1.0 ml/min,and the detection wavelength was 248 nm.Results The methodological verification showed that ketoconazole,mupirocin and mometasone furoate had a good linearity(r≥0.9995).The inter/intra-day precisions were less than 3.0%,The recovery rates were between 90%and 108%.The stability and repeatability of RSD were also less than 3.0%,which met the requirements of method validation.The contents of the three components in three batches were determined by the new method.Conclusion The method is simple and reliable.It can provide a basis for the quality control of compound ketoconazole ointment and lay a foundation for its quality standard research.