高效液相色谱法测定复方醋酸泼尼松乳膏的含量

Determination of Prednisone Acetate in Compound Prednisone Acetate Cream by RP-HPLC

目的：建立以高效液相色谱法测定复方醋酸泼尼松乳膏中醋酸泼尼松含量的方法。方法：色谱柱为Hypersil C18（4.6 mm×200 mm,10μm）,流动相为甲醇-水（60∶40）,检测波长为240 nm,柱温为30℃,进样20μL,用甲醇水浴加热溶解乳膏,冰浴过滤去掉基质后进样测定。结果：复方醋酸泼尼松乳膏中醋酸泼尼松线性范围为6.09~101.5μg/mL,回归方程为C=0.01878A-0.04193,r=0.9999。醋酸泼尼松低、中、高3种浓度的平均回收率分别为99.7%、99.6%、100.2%,RSD分别为0.72%、0.75%、1.05%,结论：本方法操作简便,结果准确,重现性好,可用于复方醋酸泼尼松乳膏的质量控制。

Objective：To establish an HPLC method to determine the concentration of prednisone acetate in Compound Prednisone Acetate Cream.Methods：The column was Hypersil C18 column（4.6 mm×200 mm,10 μm）,the mobile phase was methanol and water（60∶40）,the detecting wavelength was 240 nm,the temperature of the column was 30 ℃ and the sample size was 20 μL.The cream was dissolved in methanol in water bath.The mixture was filtered after ice bath to get the filtered liquor as sample.Results：The average recovery rates of low,moderate and high concentration of Compound Prednisone Acetate Cream were 99.7%,99.6% and 100.2% respectively and RSD were 0.72%,0.75% and 1.05% respectively.The linear range was 6.09~101.5 μg/mL and the regression equation was C=0.01878A-0.04193,r=0.9999.Conclusions：The method is simple,accurate and with good reproduction quality.It can be used to control the quality of Compound Prednisone Acetate Cream.