摘要
目的:制定氯霉素氢化可的松滴耳液质量控制标准,为临床应用提供参考。方法:应用Agilent Zorbax Eclipse XDB-C18(4.6 mm×150 mm,5μm)色谱柱,以水-乙腈(75∶25)为流动相,检测波长为245 nm,同时测定氯霉素和氢化可的松的含量。结果:氯霉素在0.051 0-0.203 8 mg/m L范围内与峰面积线性关系良好(r=0.9999),氢化可的松在0.053 3-0.213 2 mg/m L范围内与峰面积线性关系良好(r=0.9999),平均回收率分别为99.14%、98.77%,RSD分别为1.72%,1.37%%(n=6)。结论:本研究建立的质量标准方法简便、快捷,重现性好,可用于氯霉素氢化可的松滴耳液的质量控制。
Objective: To establish a method for quality control of chloramphenicol and hydrocortisone ear drops. Methods: HPLC method was need with Agilent Zorbax Eclipse XDB-C18column( 4. 6 mm × 150 mm,5 μm),the mobile phase was water-acetonitrile( 75∶ 25),the detecting wavelength was at 245 nm. Results: The linear range of chloramphenicol was 0. 0510 - 0. 2038 mg/m L( r = 0. 9999),the linear range of hydrocortisone was 0. 0533 - 0. 2132 mg/m L( r = 0. 9999),the average were 99. 14% and 98. 77%,the RSD were 1. 72% and 1. 37%( n = 6). Conclusion: The method is simple,accurate and suitable for the quality control of chloramphenicol and hydrocortisone ear drops.
出处
《儿科药学杂志》
CAS
2015年第11期49-51,共3页
Journal of Pediatric Pharmacy
关键词
高效液相色谱法
氯霉素
氢化可的松
滴耳液
质量控制
High-performance liquid chromatography
Chloramphenicol
Hydrocortisone
Ear drops
Quality control