摘要
目的 :建立加替沙星注射液的制备和质量控制方法。方法 :确定注射剂的配置工艺 ,以HPLC法测定加替沙星的含量 ,进行稳定性考察。结果 :本品制剂质量稳定 ,用HPLC法测定含量 ,平均回收率 1 0 0 3%,重复性试验RSD为 1 75 %。结论 :制备工艺可行 ,质量稳定 ,质量控制方法可靠。
Objective: To establish a method for the preparation and quality control of gatifloxcin for injection. Methods:The preparation method for injection was employed. Gatifloxcin was determined by HPLC, and the stabitity was studied. Results: The preparation was stable. Content was determined by HPLC. The average recovery was 100 3%, and RSD was 1 75%. Conclusion: The preparation was practicable, the method for quality control was convenient, and the quality was stable.
出处
《药学进展》
CAS
2004年第10期461-464,共4页
Progress in Pharmaceutical Sciences
