复方地塞米松夫西地酸乳膏含量测定

Determination of dexamethasone acetate and fusidic acid in compound dexamethasone and fusidic acid cream

目的建立测定复方地塞米松夫西地酸乳膏(地夫霜)中醋酸地塞米松和夫西地酸含量的方法。方法采用高效液相色谱法测定醋酸地塞米松和夫西地酸含量,采用十八烷基硅烷键合硅胶为填充剂;选择0.05mol/L磷酸溶液-乙腈-甲醇(40:50:10)作为流动相;测定波长为239nm。结果两组分线性范围良好(r=0.9999),重复性好(RSD<2.0%,n=6),醋酸地塞米松回收率为99.2%,夫西地酸回收率为99.6%。结论方法学验证试验结果表明制定的含量测定方法准确、可靠,可用于地夫霜质量可控。

Objective To establish a method for determination of dexamethasone acetate and fusidic acid in compound dexamethasone and fusidic acid cream. Methods The content of dexamethasone acetate and fusidic acid were determinated by HPLC. The C18 was used as analytical column. Mobile phase consisted of 0.05mol/L phosphoric acid-acetonitrile-methanol（40：50：10） and the detection wavelength was set at 239nm. Results The linearities were good（r〉0.999）, the precision of the method were good（RSD〈2.0%, n=6）, and the recoveries of dexamethasone acetate were 99.2% and fusidic acid were 99.6%. Conclusion The method is accurate and sensitive, and can be used for the analysis of compound dexamethasone and fusidic acid cream.