RP—HPLC法测定醋酸氢化可的松乳膏中醋酸氢化可的松的含量

目的：建立了RP—HPLC法测定醋酸氢化可的松乳膏中醋酸氢化可的松的含量。方法：采用AgilentHC C18（4．6IDATI×250mm，5μm）色谱柱，乙腈-水（36：64）为流动相，检测波长254nm，流速1．0ml／min，柱温40℃。结果：醋酸氢化可的松在0．506～202．4μg／ml浓度范围内呈良好线性关系（r=0．99999）；醋酸氢化可的松乳膏的平均回收率为99．28％，RSD为0．42％（n=9）。结论：该方法快速、简便、准确、灵敏、重现性好，并能有效控制药品质量。

Determination of hydrocortisone acetate in cream by RP-HPLC

Objective ：An HPEC method was developed for the determination of the content of hydrocortisone acetate in hydrocortisone acetate cream. Method：An Agilent HC C18 （4.6 mm × 250 mm,5 μm）column at 40 ℃ was used as the stationary phase with a mobile phase consisting of a mixture of acethane and water （36： 64）. The flow rate of the mobile phase was 1.0 ml/min. An ultraviolet detection was performed at the wavelength of 254 nm. Results ：The liner range of hydrocortisone acetate was between 0.506 μg/ml and 202.4 μg/ml （ r = 0.999 9 ）. The average recovery of hydrocortisone acetate from its cream was 99.28% （ n = 9 ） with an RSD% of 0.42%. Conclusion ：This method is rapid, simple, accurate and sensitive, and can be used for the quality control of hydrocortisone acetate cream. The method, as an official one ,has been included in Chinese Pharmacopeia （2010 edition）.