摘要
目的考察葡萄糖酸依诺沙星溶液的稳定性。方法采用紫外分光光度法测定溶液中葡萄糖酸依诺沙星含量,HPLC法测定有关物质含量,考察了不同pH值的葡萄糖酸依诺沙星溶液在光照及高温条件下的质量变化。结果葡萄糖酸依诺沙星溶液在光照下易变色pH值5.5～6.0溶液在高温、光照5d后即出现结晶。pH值3.0～4.0溶液在光照条件下含量下降较多,有关物质增加较多。pH在4.0～5.5之间的葡萄糖酸依诺沙星溶液稳定性较好。结论本品应遮光保存,液体制剂的pH值范围确定在4.0～5.5之间较好。
Objective To study stability of enoxacin gluconate solution. Methods The content of enoxacin gluconate solution was determined by UV spectrophotometry.The related substances was determined by HPLC. The stability of enoxacin gluconate solution under different pH value was investgated on the condition of light and heat. Results On the condition of light the color of enoxacin gluconate solution toke place changes, when the pH value of solution was at 5.5～6.0 for five days the crystal appeared. When the pH value was at 3.0～4.0 the content of enoxacin gluconate solution decreased quickly and the related substances increased. When the pH value was at 4.0～5.5 enoxacin gluconate solution was stable. Conclusions It should be avoided by strong light when store. As an injection the good range of pH value was 4.0～5.5.
出处
《药品评价》
CAS
2004年第1期37-38,共2页
Drug Evaluation
