氯霉素羊毛脂软膏中氯霉素含量和有关物质测定方法的改进

Improvement of the method for the determination of content and related substances in chloramphenicol and lanolin ointment

目的：建立HPLC方法测定氯霉素的羊毛脂软膏中氯霉素的含量和有关物质。方法采用高效液相色谱法,色谱柱：安捷伦 C18色谱柱（4．6 mm ×250 mm,5μm）,流动相：0．01 mol/L 庚烷磺酸钠缓冲溶液-甲醇（68∶32）,检测波长：277 nm,进样量：20μL。结果氯霉素在49．96~199．84μg/mL的浓度范围内与峰面积积分值呈良好的线性关系,精密度、稳定性和重复性试验结果良好,平均回收率为99．12%,RSD为0．51%（n=9）,氯霉素与其他杂质的分离度良好。结论该方法具有良好地准确度、精密度、专属性,能良好的控制氯霉素羊毛脂软膏的质量。

Objective To establish an HPLC method for the determination of content and related substances in chloramphenicol and lanolin ointment. Methods The determination was performed on Agilent C18 column （4. 6 mm ×250 mm,5 μm） with the mobile phase of 0. 01 mol/L sodium heptanesulfonate-methanol （68∶32）. The detection wavelength was 277 nm and the sample size was 20 μL. Results The linear range of the chloramphenicol was 49. 96~199. 84 μg/mL with an average recovery of 99. 12% （RSD=0. 51%,n=9）. The test had good results of pre-cision,stability,repeatability and resolution. Conclusion The method is accurate,precise and specific for the quality control of chloramphenicol and lanolin ointment.