氯霉素氢化可的松滴耳液质量标准研究

Study on Quality Standard of Chloramphenicol and Hydrocortisone Ear Drops

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.