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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 develop chloramphenicol hydrocortisone ear drops quality control standards for clinical application. METHODS: The mobile phase was Agilent-Zorbax Eclipse XDB-C18 (4.6 mm × 150 mm, 5 μm) with a mobile phase of water-acetonitrile (75:25) at a detection wavelength of 245 nm. Chloramphenicol and hydrocortisone Content. RESULTS: Chloramphenicol had a good linear relationship with the peak area (r = 0.9999) in the range of 0.051 0-0.203 8 mg / m L, and the linear relationship between peak area and area of hydrocortisone in the range of 0.053 3-0.213 2 mg / m L (R = 0.9999). The average recoveries were 99.14% and 98.77%, respectively, and the RSDs were 1.72% and 1.37% respectively (n = 6). Conclusion: The quality standard established in this study is simple, rapid and reproducible. It can be used for the quality control of chloramphenicol hydrocortisone ear drops.