摘要
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.
出处
《江西中医学院学报》
2014年第4期80-81,86,共3页
Journal of Jiangxi College of Traditional Chinese Medicine
关键词
曲安奈德益康唑乳膏
HPLC
防腐剂
苯甲酸
Triamcinolone acetonide and econazole nitrate cream
HPLC
Preservatives Benzoic acid
