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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·ml-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 a method for the determination of chloramphenicol and salicylic acid and its related substances in compound chloramphenicol solution by high performance liquid chromatography. METHODS: The column was Eclipse XDB-C18 (150 mm × 4.6 mm, 5 μm) with a mobile phase of 0.8% acetic acid in acetonitrile (60:40) at a flow rate of 1.0 ml · min- Detection wavelength of 290 nm (of which the detection wavelength of the relevant substances 272 nm), injection volume of 10μl, external standard method to calculate the content. Results: Chloramphenicol and salicylic acid could be completely separated from the related substances. The linear range of chloramphenicol was 14.88-297.60μg · ml-1 (r = 0.999 9), and the linear range of salicylic acid was 9.72-194.40μg · Ml-1-1 (r = 1.000 0). The average recoveries of chloramphenicol and salicylic acid were 101.18% and 99.78%, respectively, with RSDs of 0.82% and 0.27% (n = 9), respectively. Conclusion: The method is simple, reproducible and accurate. It can be used for the simultaneous determination of two major components in the compound chloramphenicol solution and related impurities.