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目的:建立高效液相色谱法同时测定丁氯麻滴眼液中盐酸麻黄碱、盐酸丁卡因、氯霉素三种成分的含量。方法:采用Kromasil C_(18)柱(250mm×4.6mm,5μm),流动相为甲醇-水-三乙胺-冰醋酸(40:60:0.5:0.5),流速1ml·min~(-1),检测波长为254nm,柱温为30℃。结果:盐酸麻黄碱进样量在0.51～2.56μg范围内线性关系良好(r=0.999 8),平均回收率为97.6%,RSD为1.6%。盐酸丁卡因进样量在0.47～2.34μg范围内线性关系良好(r=0.999 8),平均回收率为99.2%,RSD为1.9%。氯霉素进样量在0.26～1.13μg范围内线性关系良好(r=0.998 9),平均回收率为97.0%,RSD为1.9%。结论:该法准确,重现性好,效率高,操作简便,是丁氯麻滴眼液质量控制的有效方法。
OBJECTIVE: To establish a method for the simultaneous determination of three components of ephedrine hydrochloride, tetracaine hydrochloride and chloramphenicol in Dingchuma ophthalmic solution by high performance liquid chromatography. METHODS: Kromasil C 18 column (250 mm × 4.6 mm, 5 μm) was used with a mobile phase of methanol - water - triethylamine - glacial acetic acid (40:60:50:50) at a flow rate of 1 ml · min -1 , The detection wavelength was 254nm, the column temperature was 30 ℃. Results: The linear range was 0.51 ~ 2.56μg (r = 0.999 8). The average recovery was 97.6% and the RSD was 1.6%. The linearity of tetracaine hydrochloride injection ranged from 0.47 to 2.34 μg (r = 0.999 8) with an average recovery of 99.2% and a RSD of 1.9%. The linearity of chloramphenicol in the range of 0.26-1.13 μg was good (r = 0.998 9), with an average recovery of 97.0% and a RSD of 1.9%. Conclusion: The method is accurate, reproducible, high efficiency, easy to operate, is an effective method of quality control of Dinglumejue eye drops.