摘要
建立HPLC同时测定复方丙酸氯倍他索涂膜剂中丙酸氯倍他索和水杨酸的含量的方法。方法采用HPLC梯度洗脱色谱分离。色谱柱:Agilent ZORBAX SB-C18柱;流动相A:0.05 mol/L磷酸二氢钾(用80%磷酸溶液调节pH 2.6),B:甲醇;流速:1.0 mL/min;检测波长:240 nm;柱温:室温。结果丙酸氯倍他索、水杨酸的线性范围分别在0.2512～10.048μg/mL(r=0.9999)和10.23～122.76μg/mL(r=0.9999),平均回收率分别为97.6%,RSD=0.7%(n=6)和96.8%,RSD=0.3%(n=6)。结论该法简单,灵敏,结果准确,可用于复方丙酸氯倍他索涂膜剂的质量控制。
Objective To establish an HPLC method for simultantous determination of clobetasol propionate and salicylie acid in the compound clobetasol propionate balm. Methods A Agilent ZORBAX SB-C18 column, 0.05 mol/ L potassium dihydrogen phosphate （adjusted pH to 2.6 with 80% phosphoric acid）（A）-methanol（B） was used as the mobile phase at a flow rate of 1.0 mL/min, the detection wavelength was 240 nm,the temperature of column was room temperature. Results Clobetasol propionate had a good linearity （r=0.9999） in the range of 0.2512- 10.048 μg.ml-1 , the average recovery was 97.6%, RSD=0.7% （n=6）. Salicylic acid had a good linearity （r=0.9999） in the range of 10.23-122.76 μg.mL （r=0.9999）, the average recovery was 96.8%, RSD=0.3% （n=6）. Conclusion The method is simple, sensitive, accurate, and can be used for the content determination of the compound clobetasol propionate balm.
出处
《食品与药品》
CAS
2012年第11期430-432,共3页
Food and Drug
