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  

Determination of three constituents in compound ketoconazole ointment by RPHPLC

作　　者：吴博 王铁柱 拜年 刘冰[1] 宋洪涛 WU Bo;WANG Tiezhu;BAI Nian;LIU Bing;SONG Hongtao(Department of Pharmacy,The First Affiliated Hospital of Xinjiang Medical University,Urumqi 830000,China;Department of ICU,Affiliated Chinese Medicine Hospital of Xinjiang Medical University,Urumqi 830000,China;Department of Pharmacy,No.900 Hospital of Joint Logistics Support Force of the PLA,Fuzhou 350025,China)

机构地区：[1]新疆医科大学第一附属医院药剂科,新疆乌鲁木齐830000 [2]新疆医科大学第四附属医院重症医学科,新疆乌鲁木齐830000 [3]中国人民解放军联勤保障部队第九〇〇医院药学科,福建福州350025

出　　处：《药学实践杂志》2021年第2期152-156,共5页Journal of Pharmaceutical Practice

摘　　要：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。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.

关 键 词：反相高效液相色谱法 酮康唑 莫匹罗星 糠酸莫米松 

分 类 号：R917[医药卫生—药物分析学]