复方氯霉素醇溶液中两组分含量测定及有关物质检查

Determination of Two Components and Related Substances in Compound Chloramphenicol Alcoholic Solutions

目的：建立高效液相色谱法测定复方氯霉素醇溶液中氯霉素、水杨酸含量及其有关物质的检查方法。方法：色谱柱为Eclipse XDB-C18柱（150 mm×4.6 mm,5μm）,流动相为0.8%冰醋酸溶液-乙腈（60∶40）,流速为1.0 ml·min^-1,柱温25℃,检测波长290 nm（其中有关物质检查检测波长为272 nm）,进样量为10μl,外标法计算含量。结果：氯霉素及水杨酸与有关检查物质能完全分离,氯霉素的线性范围为14.88-297.60μg·m^l-1（r=0.999 9）,水杨酸的线性范围为9.72-194.40μg·ml-1^-1（r=1.000 0）;氯霉素与水杨酸的平均回收率分别为101.18%,99.78%,RSD分别为0.82%,0.27%（n=9）。结论：该方法操作简便、重复性好、结果准确,可用于同时测定复方氯霉素醇溶液中两种主要成分的含量与有关杂质的检查。

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 resolution, reproducibility and sensitivity. It is suitable for the determination of the two components and related substances in compound chloramphenicol alcoholic solutions.