HPLC法测定酮康唑乳膏中酮康唑和甲硝唑的含量

HPLC Determination of Ketoconazole and Metronidazole in Ketoconazole Cream

目的建立HPLC法测定酮康唑乳膏中酮康唑和甲硝唑的含量。方法色谱柱为HypersilODSC18柱(250mm×4.6mm,5μm)大连依利特公司;流动相为甲醇∶水=60∶40;DAD检测器,检测波长为258nm。结果在建立的色谱条件下,酮康唑与有关杂质能有效地分离。酮康唑在0.223～4.46μg,甲硝唑在0.106～2.12μg进样量范围内与峰面积有良好的线性关系,相关系数分别为0.9989和0.9999,平均回收率为97.23%,RSD为2.25%(n=3)。结论本法操作简单,结果准确可靠,可用于酮康唑乳膏的质量控制。

Objective To determine the amount of ketoconazole and metronidazole in ketoconazole cream by HPLC.Methods A Hypersil ODS C_~18 column(250mm×4.6mm,5μm);The mobile phase consisted of methanol-water (60∶40);Detection was at 258 nm.Results The standard curves of ketoconazole and metrondiazole were linear over the range of 0.223～4.46μg(r=0.9989) and 0.106～2.12μg(r=0.9999) respectively;The average recoveries reached 97.23%,RSD was 2.25%(n=3).Conclusions The method is simple,reliable,and can be used for quality control of ketoconazole cream.