HPLC法同时测定地米樟酚乳膏中醋酸地塞米松、樟脑和苯酚的含量

Simultaneous determination of dexamethasone acetate,camphor and phenol in compound cream by HPLC method

目的建立以HPLC法同时测定地米樟酚乳膏中醋酸地塞米松、樟脑和苯酚含量的方法。方法色谱柱为SHIADZU-GL Inertsil~ RODS-3 RP C_(18),流动相为甲醇-水(60∶40),检测波长为285 nm,流速为1.0 ml/min,柱温为40℃,外标法定量。结果醋酸地塞米松、樟脑和苯酚的线性范围分别为4.024~40.24、101.7~2 033和10.38~425.2μg/ml,相关系数r>0.999 5;三者的平均回收率分别为101.2%(RSD为0.56%)、99.89%(RSD为0.72%)、100.2%(RSD为0.97%);重复性试验中RSD均小于1.5%。结论本方法简便、准确,重复性好,可用于地米樟酚乳膏的质量控制。

Objective To establish a HPLC method for simultaneously determining the content of dexamethasone acetate, camphor and phenol in compound cream.Methods The separation was performed on a SHIADZU-GL Inertsil ODS-3 RP C18 analytical column with the mobile phase consisting of methanol-water （60：40）. The flow rate was 1.0 ml/min. The detection wave length was 285 nm and the column temperature was 40℃.Results Dexamethasone acetate,camphor and phenol showed good linearity （r〉0.999 5, n=7） within the concentration range of 4.024-40.24,101.7-2 033 and 10.38-425.2 μg/ml,respectively. The average recovery of dexamethasone acetate, camphor and phenol was 101.2%（RSD was 0.56%）,99.89%（RSD was 0.72%）,100.2%（RSD was 0.97%）,respectively. Moreover, the RSDs were less than 1.5% in the repeated tests. Conclusion The method was simple, quick and accurate. It is suitable for the quality control of dexamethasone acetate camphor and phenol cream.