盐酸加替沙星滴耳液的制备及质量控制

Preparation and quality control of gatifloxacin hydrochloride ear drops

目的 建立盐酸加替沙星滴耳液的制备及质量控制方法。方法 采用紫外分光光度法测定加替沙星含量 ,并进行稳定性、刺激性观察。结果 盐酸加替沙星在 1.6 - 8.0μg· ml- 1 (r=0 .9999)范围内 ,吸收度与浓度呈良好的线性关系 ,平均回收率为 99.8% ,RSD为 0 .5 9%。结论 本制剂制备工艺合理 ,质控方法简便、可靠。

Objective To establish the preparation process and method for quality control of gatifloxacin hydrochloride ear drops. Methods The content and the stability and stimulation of gatifloxacin hydrochloride ear drops were determined by ultravoilet spectro photometry. Results The calibration curves was linear when the gatifloxacin hydrochloride concentration was 1.6 8.0 μg·ml -1 ( r =0.9999). The average recovery was 99.8% with RSD of 0.59%( n =5). Conclusion The ear drops is simple in preparation, good in stability and slight in irritability, and the method for quality control is simple, rapid and accurate.