高效液相色谱法测定氯麻滴鼻液含量及降解产物的控制  

Determination of Content and Related Substances of Chloramphenicol andEphedrine Hydrochloride Nasal Drops by HPLC

作　　者：邹积汉 王宝才 刘敏 于青伟 邓翔 

机构地区：[1]湖北鄂州鄂钢医院,湖北鄂州436002

出　　处：《中国药业》2007年第3期22-23,共2页China Pharmaceuticals

摘　　要：目的建立同时测定氯麻滴鼻液中氯霉素、盐酸麻黄碱及氯霉素降解产物氯霉素二醇物的方法。方法采用Zorbax Eclipse XDB-C8色谱柱(150mm×4.6mm,5μm),流动相为0.02mol/LKH2PO4(用磷酸和三乙胺调节pH值为4.0)-甲醇(65:35),检测波长为220nm,柱温30℃,流速为1.0mL/min。结果制剂中其他成分不干扰测定,3种被测成分分离良好。氯霉素和盐酸麻黄碱的线性范围分别为12.8～127.7mg/L(r=0.9998,n=6)和50.9～509.2mg/L(r=0.9994,n=6),模拟回收率分别为100.4%和99.8%,日内RSD分别为0.36%(n=5)和0.56%(n=5),日间RSD分别为0.55%(n=5)和0.86%(n=5)。结论该方法简单、快速、准确,可满足氯麻滴鼻液的稳定性要求。Objective To establish a HPLC method for determination of chloramphenicol and its related substances and ephedrine hydrochloride in its nasal drops. Methods The stationary phase was Zorbax Eclipse XDB- C8 （150 mm ×4. 6 mm, 5 μm）. The mobile phase was 0. 02 mol/L KH2PO4 （adjusting pH value to with H3PO4 and triethylamine）-methanol （65：35）. UV detection wavelength was at 220 nm with flow rate 1.0 mL/min and column temperature 30℃. Results The other components in the preparation did not interfere with the determination. The linear ranges of chloramphenicol and ephedrine hydrochloride were 12. 8 - 127.7 mg/L（ r =0. 999 8, n =6） and 50. 9 -509. 2 mg/L （ r =0. 999 4, n =6）respoctively. The average recovery rates of chloramphenicol and ephedrine hydrochloride were 100. 4% and 99. 8%respoctively. RSD of inter - day were 0. 36% （ n = 5） and 0. 56% （ n = 5）, RSD of intra - day were 0. 55% （ n = 5） and 0. 86% （ n = 5）. Conclusion The method is simple, rapid and accurate, and can be used for the stability study of chlorampbenicol and ephedrine hydrochloride nasal drops.

关 键 词：氯霉素 盐酸麻黄碱 氯霉素二醇物 高效液相色谱法 

分 类 号：R927[医药卫生—药学]