HPLC法测定氯霉素滴眼液中氯霉素及其氯霉素二醇物含量

摘要

Objective: To establish a RP-HPLC method for determining of the content of Chloramphenicol and glycols inChloramphenicol eye drops. Methods: Agilent Eclipse XDB-C18 (5 μm, 4.6 mm×150 mm) was used as the analytical column,acetonitrile-water -acetic acid (40.0:60.0:0.5) was used as mobile phase with the flow rate was 1.0 ml/min, the detection wavelength was 272 nm and the column temperature was at 30℃, the sample size was 10 μl. Results: The average recovery and RSD were 99.48％ and 0.40％ for Chloramphenicol, 100.36％ and 0.42％ for glycols; Chloramphenicol, glycols showed a good linear relationship in the following ranges of conc:entration: 10.96-109.60 μg/ml (r=0.999 9), 1.95-39.00 μg/ml (r=0.999 5). Conclusion: The method is good in the aspect of resolution, reproducibility and sensitivity. It is recommended that the method can be used to determine the content of Chloramphenicol and glycols in Chloramphenicol eye drops.%目的:建立反相高效液相色谱(HPLC)法测定氯霉素滴眼液中氯霉素及其分解产物氯霉素二醇物含量的方法.方法:采用Eclipse XDB-C18柱(5 μm,4.6 mm×150 mm);流动相:乙腈-水-冰醋酸(40.0∶60.0∶0.5);流速:1.0 ml/min;检测波长:272 nm;柱温:30℃;进样量:10 μl.结果:氯霉素与氯霉素二醇物的平均回收率分别为99.48%、100.36%,RSD值分别为0.40%、0.42%;氯霉素的线性范围为10.96～109.60 μg/ml(r=0.999 9),氯霉素二醇物的线性范围为1.95～39.00 μg/ml(r=0.999 5).结论:该方法操作简便、重现性好、结果准确,建议作为医院制剂含量测定的检验方法.