Preparation and Quality Contorl of Econazole Nitrate Ear-drops / 中国药房

ABSTRACT

OBJECTIVE:To establish the preparation process and method of quality control of econazole nitrate ear-drops.METHODS:With mixture of glycerin and 75% alcohol as solvent,econazole nitrate ear-drops was prepared and the content of econazole was determined by ultraviolet spectrophotometry.The stability,irritation and in vitro antimicrobial tests were carried out.RESULTS:There was a good linearity of calibration curve of econazole in range of 200～600?g/ml,r=0.9 999,the average recovery was 100.76%,RSD=0.82%(n=5).The in vitro antimycotic MICs of econazole nitrate in ear-drops were 2?g/ml and 4?g/ml against standard and clinically isolated strains of Candida albicans respectively.CONCLUSION:The ear-drops is simple in preparation,effective in antimycotic action,good in stability and slight in irritability,and the method of quality control is simple,rapid and accurate.