用RP-HPLC法同时测定蒽柳他索涂膜中水杨酸、丙酸氯倍他索和地蒽酚的含量  

Simultaneous determination of contents of salicylic acid,clobetasol propionate and dithranol in enliutasol film coating by RP-HPLC method

作　　者：姜泽静 陈中建 

机构地区：[1]上海市皮肤病医院药剂科,上海200443

出　　处：《药学服务与研究》2013年第2期124-126,共3页Pharmaceutical Care and Research

摘　　要：目的:建立RP-HPLC法同时测定蒽柳他索涂膜中水杨酸、丙酸氯倍他索及地蒽酚的含量。方法:采用Phenomenex Luna C18色谱柱(150mm×4.6mm,5μm);以甲醇-0.4%磷酸溶液梯度洗脱;流速为1.0ml/min;检测波长为240nm;柱温为室温;进样量20μl。结果:水杨酸、丙酸氯倍他索及地蒽酚分别在3.112～115.6μg/ml(r=0.999 8)、1.016～50.80μg/ml(r=0.999 9)和1.040～52.00μg/ml(r=0.999 7)范围内呈良好的线性关系。3种成分的精密度RSD值分别为0.96%、2.10%和2.46%。水杨酸、丙酸氯倍他索及地蒽酚的低、中、高浓度的平均加样回收率分别为(98.80±1.87)%、(101.05±1.10)%、(100.51±1.59)%;(98.92±1.71)%、(100.74±1.90)%、(101.56%±1.49)%;(101.37±2.58)%、(102.60%±1.14)%、(98.17%±0.93)%。结论:本方法准确、简便、快速,可用于蒽柳他索涂膜的含量测定。Objective： To establish a RP-HPLC method for determination of the contents of salicylic acid,clobetasol propionate and dithranol in enliutasol film coating.Methods： Separation was performed on Phenomenex Luna C18 column（150 mm×4.6 mm,5 μm） with the mobile phase of methanol-0.04% phosphoric acid solution gradient elution at a flow rate of 1.0 ml/min.The detection wavelength was 240 nm and the injection volume was 20 μl.Results： Salicylic acid,clobetasol propionate and dithranol displayed good linearity within the ranges of 3.112-115.6 μg/ml（r=0.999 8）,1.016-50.80 μg/ml（r=0.999 9） and 1.040-52.00 μg/ml（r=0.999 7）,and the precision RSD were 0.96%,2.10% and 2.46%,respectively.The average recovery rates of low,medium and high concentrations of salicylic acid,clobetasol propionate and dithranol were（98.80±1.87）%,（101.05±1.10）%,（100.51±1.59）%;（98.92±1.71）%,（100.74±1.90）%,（101.56±1.49）%;（101.37±2.58）%,（102.60±1.14）%,（98.17%±0.93）%,respectively.Conclusion： It is an accurate,sensitive and reproducible method for the determination of 3 contents in enliutasol film coating.

关 键 词：蒽柳他索 水杨酸 丙酸氯倍他索 地蒽酚 涂膜 色谱法 高效液相 

分 类 号：R927.2[医药卫生—药学]