摘要
目的建立复方氯霉素滴耳液的质量标准。方法采用高效液相色谱法对复方氯霉素滴耳液中的氯霉素和地塞米松磷酸钠进行定性鉴别及含量测定。结果在高效液相色谱法中,氯霉素在0.02652～0.2122mg/mL范围内线性关系良好(r2=0.9999),平均回收率为99.2%,RSD=0.19%;地塞米松磷酸钠在0.01068～0.08262mg/mL范围内线性关系良好(r2=0.9999),平均回收率为101.5%,RSD=0.47%。结论所建立的方法能可靠准确地进行定性定量测定,可用于复方氯霉素滴耳液的质量控制。
Objective To establish a method for the quality control of compound chloramphenicol auristillae. Methods The discrimination and determination of compound chloramphenicol auristillae were performed by the high performance liquid chromatography (HPLC). Results The linear range for chloramphenicol was 0.02652~0.2122mg/mL ,the average recovery rate was 99.2%,RSD was 0.19%;The linear range for Dexamethasone Sodium Phosphate was 0.01068~0.08262mg/mL ,the average recovery rate was 101.5%,RSD was 0.47%. Conclusion The method is reliable and accurate, and can be applied to the quality control of compound chloramphenicol auristillae.
出处
《中国医药指南》
2013年第8期46-47,共2页
Guide of China Medicine
关键词
复方氯霉素滴耳液
氯霉素
地塞米松磷酸钠
高效液相色谱法
Compound chloramphenicol ear drops
Chloramphenicol
Dexamethasone sodium phosphate
Performance liquid chromatography
