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目的研究巴洛沙星在光、热、湿等因素影响下的稳定性。方法通过高效液相色谱法观察巴洛沙星在高温60℃、高湿(92±5)%RH、光照(4 500±500)Lx条件下的外观性状、水分、有关物质的变化。结果巴洛沙星在高温条件下水分由8.7%降至2.5%;在光照条件下,外观性状变成黄色结晶性粉末,新增光降解杂质两种。结论巴洛沙星在光、热、湿等因素影响下的稳定性差,包装、贮藏应避免高温、光照。
Objective To study the stability of balofloxacin under the influence of light, heat and humidity. Methods The appearance, water content and related substances of balofloxacin were observed by high performance liquid chromatography (HPLC) at 60 ℃, high humidity (92 ± 5)% RH and light illumination (4 500 ± 500) Lx. Results Barofloxacin reduced the water content from 8.7% to 2.5% under high temperature conditions. Under light conditions, the appearance properties turned into yellow crystalline powder and added photodegradable impurities. Conclusion Balofloxacin has poor stability under the influence of light, heat, humidity and other factors. Packaging and storage should avoid high temperature and light.