HPLC测定复方莫西沙星滴耳液中的莫西沙星和地塞米松

Determination of moxifloxacin hydrochloride and dexamethasone acetate in Compound moxifloxacin ear drops by HPLC

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（150mm×4．6mm，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1．0ml·min^-1；检测波长为241nm；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 establish an HPLC method for determination of moxifloxacin hydrochloride and dexamethasone acetate in Compound moxifloxacin ear drops simultaneously. METHODS The chromatographic column was SHIM - PACK VP - ODS（ 150 mm× 4.6 mm,5 μm）, with column temperature of 30℃. The mobile phase consisted of phosphate buffer solution（ which contained 0.02 mol · L^-1 sodium dihydrogen phosphate and 0.3% triethylamine） - methanol（40 ： 60, adjust pH to 3.0 by phosphoric acid）, The flow rate was 1.0 ml·min^-1 and the detection wavelength was at 241 nm and the injected volume was 20 μl. RESULTS The calibration curve for moxifloxacin hydrochlofide was linear between 0.3 -2.4μg （r =0, 9999 ,n =5 ） and the average recovery rate was 98.73% with RSD of 0.89%. The calibration curve for dexamethasone acetate was linear between 0.03 - 0.24 μg （ r = 0.9999, n = 5） and the average recovery rate was 98.24% with RSD of 0.75%. CONCLUSION The method is simple, rapid, accurate, reproducible and can be used for quantity control of compound moxifloxacin ear drops.