高效液相色谱法同时测定复方甲硝唑散中甲硝唑、盐酸丁卡因及醋酸地塞米松的含量

Simultaneous Content Determination of Metronidazole,Tetracaine Hydrochloride and Dexamethasone Acetate in Metronidazole Compound Powder by HPLC

目的:建立以高效液相色谱法同时测定复方甲硝唑散中甲硝唑、盐酸丁卡因及醋酸地塞米松含量的方法。方法:色谱柱为C18,流动相为甲醇-水-三乙胺(65∶35∶0.36),检测波长甲硝唑、盐酸丁卡因为310nm,醋酸地塞米松为240nm,流速为1ml/min,柱温为25℃。结果:甲硝唑、盐酸丁卡因、醋酸地塞米松进样量分别在0.412μg^2.06μg(r=0.9999)、0.191μg^0.956μg(r=0.9999)、0.121μg^0.604μg(r=0.9998)范围内线性关系良好;平均回收率分别为100.69%(RSD=1.28%)、101.37%(RSD=0.23%)、102.40%(RSD=0.89%)。结论:本方法简便、准确,重现性好,可用于复方甲硝唑散的质量控制。

OBJECTIVE： To establish HPLC method for the simultaneous content determination of metronidazole, tetracaine hydrochloride and dexamethasone acetate in metronidazole compound.METHODS： The content determination was per formed on column C18; the mobile phase consisted methanol- water-triethylamine（65 ： 35 ： 0.36）, the detection wavelength of both metronidazole and tetracaine hydrochloride was 310nm, and 240nm for dexamethasone acetate, the flow rate was 1ml/min and the column temperature was 25℃ .RESULTS：The linear ranges of metronidazole, tetracaine hydrochloride and dexamethasone acetate were 0.412μg～2.06μg（r = 0.9 999）, 0.191μg～0.956μg（r = 0.9 999） and 0.121μg～0.604μg（r = 0.9 998）, respectively, and their average recoveries were 100.69% （RSD = 1.28% ）, 101.37% （RSD = 0.23% ） and 102.40% （RSD = 0.89%）, respectively.CONCLUSION： The method was simple, accurate, reproducible, and suitable for the quality control of metronidazole compound.