HPLC法测定丁酸氢化可的松凝胶中丁酸氢化可的松的含量

Content Determination of Hydrocortisone Butyrate in Hydrocortisone Butyrate Gel by HPLC

目的:建立测定丁酸氢化可的松凝胶中丁酸氢化可的松含量的方法。方法:采用高效液相色谱法。色谱柱为Phenomen C18柱,流动相为乙腈-0.5%醋酸水溶液(51:49,V/V),检测波长为240nm,流速为1.0ml/min,柱温为25℃,进样量为20μl,灵敏度为1.0AUFS。结果:丁酸氢化可的松的进样量在97.6～878.4ng范围内与峰面积积分值呈良好的线性关系(r=0.9991);平均回收率为99.5%,RSD=0.45%(n=9)。结论:该方法简便、灵敏、准确,可用于丁酸氢化可的松凝胶的质量控制。

OBJECTIVE： To develop a method for the content determination of hydrocortisone butyrate in Hydrocortisone butyrate gel. METHODS： HPLC method was adopted. The determination was performed on Phenomen C,8 column with mobile phase consisted of acetonitrile-0.5% acetic acid （51：49） at flow rate of 1.0 ml/min. The column temperature was 25 ℃ and injection volume was 20 μ1. The sensitivity of the sample was 1.0 AUFS. RESULTS： The linear range of hydrocortisone butyrate was 97.6-878.4 ng （r=0.999 1） with an average recovery of 99.5% （RSD=0.45%, n=9）. CONCLUSION： The method is proven to be simple, accurate and precise for the quality control of Hydrocortisone butyrate gel.