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目的:研究复方氯霉素滴眼液的制备及质控方法.方法:采用反相高效液相色谱法,流动相为甲醇-0.02mol·L-1磷酸二氢钾溶液(62:38);流速为1.2ml·min-1氯霉素的检测波长为276nm,地塞米松磷酸钠的检测波长为242nm;结果:氯霉素的平均回收率为98.96%,(RSD=1.2%);地塞米松磷酸钠的平均回收率为98.53%,(RSD=0.62%)。结论:制剂有较好的适应性,质控方法快速简便,准确性较好。
OBJECTIVE: To study the preparation and quality control of compound chloramphenicol eye drops.METHODS: The mobile phase was methanol-0.02 mol·L-1 potassium dihydrogen phosphate solution (62:38) by reversed-phase high performance liquid chromatography The detection wavelength of chloramphenicol was 276 nm and the detection wavelength of dexamethasone sodium phosphate was 242 nm. The average recovery of chloramphenicol was 98.96% (RSD = 1.2%), The average recovery of the product was 98.53% (RSD = 0.62%). Conclusion: The preparation has better adaptability, quality control method is quick and easy, and the accuracy is better.