摘要
建立复方加替沙星滴耳液的制备及质量控制方法。方法:以甘油和乙醇为溶剂制备滴耳液,采用双波长分光光度法于263.2nm和360.0nm波长处测定硝酸益康唑含量,于293.0nm波长处测定盐酸加替沙星含量,并进行稳定性、刺激性考察。结果:硝酸益康唑和盐酸加替沙星的平均回收率分别为101.0%(RSD=0.80%)和99.8%(RSD=0.70%)。结论:本制剂制备工艺合理,质量控制方法可行。
Objective:To establish the preparation process and method of quality control of compound gatifloxacin ear drops.Methods:The ear drops was prepared with glycerin and alcohol as vehicle.Dual wavelength spectrophotometry was used to determine the content of econazole nitrate at 263.2 nm and 360.0 nm.The content of gatifloxacin hydrochloride was determined at 293.0 nm.The stability and stimulation of compound gatifloxacin ear drops were observed.Results:The average recovery of econazole nitrate and gatifloxacin hydrochloride was 101.0%(RSD=0.80%) and 99.8%(RSD=0.70%),respectively.Conclusion:The ear drops is simple in preparation,good in stability and slight in irritability,and the method of quality control is simple,rapid and accurate.
出处
《中国药业》
CAS
2004年第11期50-51,共2页
China Pharmaceuticals
关键词
盐酸加替沙星
硝酸益康唑
滴耳液
制备
质量控制
gatifloxacin hydrochloride
econazole nitrate
ear drops
preparation
quatity control
