Determination of Two Components and Related Substances in Compound Chloramphenicol Alcoholic Solu-tions / 中国药师

ABSTRACT

Objective:To establish an HPLC method to determine the content of chloramphenicol, salicylic acid and the related substances in compound chloramphenicol alcoholic solutions. Methods:The analytical column was Agilent Eclipse XDB-C18 (150 mm × 4. 6 mm,5 μm), 0. 8% acetic acid solution- acetonitrile(60∶40) was used as the mobile phase with the flow rate of 1. 0 ml· min-1 , the detection wavelength was 290nm for chloramphenicol and salicylic acid, and 272nm for the related substances, the column temperature was 25℃,and the injection volume was 10 μl. Results: Chloramphenicol and salicylic acid were completely separated from the related substances. The linear relationship of chloramphenicol ranged from 14. 88 to 297. 60μg·ml-1(r=0. 999 9), and the average recovery was 101. 18% with RSD of 0. 82%(n=9). The linear relationship of salicylic acid ranged from 9. 72 to 194. 40μg· ml-1(r=1. 000 0), and the average recovery was 99. 78% with RSD of 0. 27%(n=9). Conclusion:The method is good in resolu-tion, reproducibility and sensitivity. It is suitable for the determination of the two components and related substances in compound chloramphenicol alcoholic solutions.