曲安奈德益康唑乳膏中防腐剂苯甲酸含量测定

Content Determination of the Preservatives of Benzoic Acid in Triamcinolone Acetonide and Econazole Nitrate Cream

目的：建立HPLC法测定曲安奈德益康唑乳膏中防腐剂苯甲酸的含量,为该品种仿制药研发防腐剂处方设计提供依据.方法：采用HPLC方法,以外标法计算含量.结果：苯甲酸浓度在12.0～384.0μg/mL范围内呈良好线性关系,r=0.9996;平均回收率为98.8％,RSD为1.96％.结论：本方法灵敏度高、操作简便,可用于测定曲安奈德益康唑乳膏中苯甲酸的含量;其苯甲酸含量可为该品种仿制药研发提供处方依据.

Objective ：To establish an HPLC method for the determination of benzoic acid in triamcinolone acetonide and econazole ni- trate cream. To provide evidence for the designation of the generic drug. Method： The content was calculated by external standard with HPLC. Results： A good linear relationship of benzoic acid was found in the range of 12.0-384.0 μg/mL（ r = 0.9996） ;The average recoveries was 98.8% . Conclusion ： The described method can be used in the determination of the preservatives of benzoic acid in tri- amcinolone aeetonide and econazole nitrate cream, which is simple, sensitive, accurate and reliable, also the content of benzoic acid can provide evidence for the designation of the generic drug.