HPLC法同时测定丁氯麻滴眼液中三组分的含量

Simultaneous Determination the Contents of Three Constituents in Dinglvma Eye Drops by HPLC

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 HPLC method for determination the contents of ephedrine hydrochloride, tetracaine hydrochloriden and chloramphenicol in Dinglvma Eye Drops. Method： The Kromasil C18 column（250 mm ×4.6 mm,5 μm）was used, a mixture of methanol-water-trethylamine-glacial acetic acid（40： 60： 0.5：0.5 ） as mobile phase. The flow rate was 1.0 ml.min ^-1 and the detection wavelength was at 254 nm. Result： The linear ranges of ephedrine hydrochloride, tetracaine hydrochloride and chlorampheni- col were 0.51 - 2.56 μg（ r = 0.999 8 ） ,0.47 - 2.34 μg （ r = 0.999 8 ） and 0.26 - 1.13 μg （ r = 0.999 8 ）, respectively. The average recoveries were 97.6% with RSD 1.6% （ n = 9） , 99.2% with RSD 1.9% （ n = 9） and 97.0% with RSD 1.9% （ n = 9） , respectively. Conclusion： The method is simple, and accurate, it can be used for quality control of dinglrma eye drops.