HPLC法测定复方益肤乳膏中酮康唑和丙酸氯倍他索含量  

Determination of ketoconazole and clobetasol propionate in Compound Yifu Cream by HPLC

作　　者：胡志飞[1] 杜建红[2] 谢晓玲[1] 

机构地区：[1]成都军区机关第一门诊部,成都610011 [2]成都军区药品仪器检验所

出　　处：《西南国防医药》2017年第10期1043-1046,共4页Medical Journal of National Defending Forces in Southwest China

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ01-3)

摘　　要：目的采用高效液相色谱法(HPLC)建立测定复方益肤乳膏中酮康唑和丙酸氯倍他索含量的方法 ,为提高和控制本院制剂复方益肤乳膏质量标准提供依据。方法采用HPLC检测复方益肤乳膏中酮康唑和丙酸氯倍他索的含量,以甲醇-水(75:25)为流动相;检测波长为239 nm,分别进行精密度、稳定性和回收率等实验。结果酮康唑和丙酸氯倍他索分别在浓度为0.323~2.584 mg/ml和4.107~32.859μg/ml范围内,与各自峰面积均呈现较好的线性关系。在24 h内,检测结果的精密度和稳定性均好。样品回收率:酮康唑为102.54%(RSD=1.2%),丙酸氯倍他索为105.16%(RSD=1.1%)。结论采用HPLC能准确检测复方益肤乳膏中酮康唑和丙酸氯倍他索的含量,且专属性高,精密度好,回收率好,适合用于该制剂的质量控制。Objective To determine the contents of ketoconazole and clobetasol propionate in Compound Yifu Cream by high efficiency liquid chromatography（HPLC） to provide basis for improving and controlling the quality standard for Compound Yifu Cream prepared by our h ospital.Methods HPLC was adopted for determining the contents of ketoconazole and clobetasol propionate in Compound Yifu Cream,with methanol-water（75：25） as mobile phase; the check wavelength was 239 nm for precision,stability and recovery tests.Results Ketoconazole and clobetasol propionate were within the concentration range of 0.323-2.584 mg/ml and4.107-32.859 μg/ml and were in a good linear relation with respective peak area.Within 24 hours,the precision and stability of detection results were excellent.Sample recovery rate： ketoconazole 102.54%（RSD=1.2%） and clobetasol propionate 105.16%（RSD=1.1%）.Conclusion HPLC can accurately detect the contents of ketoconazole and clobetasol propionate in Compound Yifu Cream,and the specificity,precision and recovery rate is high; it is suitable for the quality control of the preparation.

关 键 词：高效液相色谱法 复方益肤乳膏 酮康唑 丙酸氯倍他索 含量 测定 

分 类 号：R965.2[医药卫生—药理学]