论文部分内容阅读
目的采用HPLC法同时测定复方莫西沙星滴耳液中的盐酸莫西沙星和醋酸地塞米松。方法采用Shim-Pack VP-C18色谱柱(150 mm×4.6 mm,5μm),柱温30℃,流动相为磷酸盐缓冲液-甲醇(40:60,磷酸调pH3.0);流速为1.0 ml.min-1;检测波长为241 nm;进样量20μl。结果盐酸莫西沙星0.3~2.4μg(r=0.9999,n=5)、醋酸地塞米松0.03~0.24μg(r=0.9999,n=5)与峰面积的线性关系良好,平均回收率分别为98.73%(RSD=0.89%)、98.24%(RSD=0.75%)。结论所建方法简便、快速、准确、重复性好,可用于复方莫西沙星滴耳液的质量控制。
Objective To determine the simultaneous determination of moxifloxacin hydrochloride and dexamethasone acetate in compound moxifloxacin ear drops by HPLC. Methods A Shim-Pack VP-C18 column (150 mm × 4.6 mm, 5 μm) was used. The column temperature was 30 ℃ and the mobile phase was phosphate buffer-methanol (40:60, .min-1; detection wavelength of 241 nm; injection volume 20μl. Results The linear relationship between moxifloxacin hydrochloride and peak area was 0.3 ~ 2.4μg (r = 0.9999, n = 5) and 0.03 ~ 0.24μg dexamethasone acetate (r = 0.9999, n = 5) with the average recoveries of 98.73 % (RSD = 0.89%), 98.24% (RSD = 0.75%). Conclusion The method is simple, rapid, accurate and reproducible. It can be used for the quality control of compound moxifloxacin ear drops.