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目的建立氯地滴眼液中氯霉素和地塞米松磷酸钠的高效液相色谱法(high performance liquidchromatography,HPLC)含量测定方法。方法采用大连依利特C_(18)色谱柱(4.6mm×200mm,5μm),P230高压恒流泵,以三乙胺溶液-甲醇乙腈(44:48:8)为流动相,流速为1.0mL/min,采用UV230紫外-可见检测器检测,检测波长242nm。结果方法的线性范围氯霉素为339.0～658.2μg/mL(r=0.999 7,n=5),平均回收率为101.8%[相对标准差(relative standard deviation,RSD)=0.45%,n=9];地塞米松磷酸钠的线性范围为37.26～72.34μg/mL(r=0.999 9,n=5),平均回收率为102.3%(RSD 0.63%,n=9)。结论本方法操作简便,结果准确、可靠,重复性好,可用于氯地滴眼液的含量测定。
Objective To establish a method for the determination of chloramphenicol and dexamethasone sodium phosphate in Chlorhexidine eye drops by high performance liquid chromatography (HPLC). Methods Dalian elite C 18 column (4.6mm × 200mm, 5μm), P230 high pressure constant current pump, triethylamine solution-methanol-acetonitrile (44: 48: 8) min, using UV230 UV - visible detector detection, detection wavelength 242nm. Results The linear range of the method was 339.0-658.2 μg / mL for chloramphenicol (r = 0.999 7, n = 5) with an average recovery of 101.8% [relative standard deviation (RSD) = 0.45%, n = 9 ]. The linear range of dexamethasone sodium phosphate was 37.26 ~ 72.34μg / mL (r = 0.999 9, n = 5). The average recovery was 102.3% (RSD 0.63%, n = 9). Conclusion The method is simple, accurate, reliable and reproducible. It can be used to determine the content of chlorhexidine eye drops.