高效液相色谱法测定氯霉素滴眼液含量及降解产物的控制

Determination of chloramphenicol eyedrops and its related substance 2-amino-1-(4-nitropheny 1)propane-1,3-diol by HPLC

目的:采用高效液相色谱法分离测定氯霉素滴眼液的含量,并对其中降解产物二醇物进行控制。方法:固定相为KromasilC18色谱柱(4.6mm×250mm,5μm);流动相为甲醇-乙腈-0.15%磷酸(1∶2∶7);流速为1.0mL·min-1,检测波长为270nm。结果:氯霉素的平均回收率为100.94%,RSD为0.49%,氯霉素二醇物的平均回收率为99.61%,RSD为0.97%。结论:本法可同时测定氯霉素滴眼液中氯霉素与氯霉素二醇物的含量,而且简便、快速、准确。

OBJECTIVE To establish an HPLC method for determination of chloramphenicol eyedrops and its related substance 2- amino-1-（4-nitropheny 1） propane-1,3-diol. METHODS Using a kromasil C18 column（4. 6 mm × 250 mm, 5μm）, with the mobile phase of methanol-acetonitrile-0. 15 % phosphoric acid （1：2：7）,at a flow rate of 1.0 mL·min^-1. The detection wavelength was 270 nm. RESULTS The average recoveries of the two substances were （ 100. 49 ± 0. 49） % and （99. 61 ± 0. 97） %, respectivelity. CONCLUSION The method is simple,rapid and sensitive,and the result is stable and with high reproducibility.