Simultaneous Determination of 2 Main Ingredients in Tobramycin and Dexamethasone Eye Drop by HPLC-Column Derivatization-Dual Wavelength Method

VernacularTitle:HPLC-柱前衍生化-双波长法同时测定妥布霉素地塞米松滴眼液中2种主成分的含量
Author: Shunzhang TAI ; Bujuan YUAN ; Kemin GONG ; Tingting ZHANG
Publication Type:Journal Article
Keywords: Tobramycin; Dexamethasone; Tobramycin and dexamethasone eye drop; HPLC-column derivatization-double wa-velength
From: China Pharmacy 2015;26(33):4731-4733
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To establish a method for the simultaneous determination of tobramycin and dexamethasone in Tobra-mycin and dexamethasone eye drop. METHODS:HPLC-column derivatization-double wavelength method was performed on the col-umn of Agilent C18 with mobile phase of 0.25% 3-hydroxymethyl aminomethane-acetonitrile-0.5 mol/L sulfuric acid(40:59:1,V/V/V)at flow rate of 1.0 ml/min,detection wavelength was 365 nm and 220 nm,column temperature was 30 ℃,and the volume in-jection was 20 μl. RESULTS:The linear range was 18.01-180.09 μg/ml for tobramycin(r=0.999 5)and 6.02-60.24 μg/ml for dexa-methasone(r=0.999 8);RSDs of precision,stability and reproducibility tests were lower than 1%;recoveries were 98.65%-100.01%(RSD=0.47%,n=9)and 98.92%-100.20%(RSD=0.50%,n=9),respectively. CONCLUSIONS:The method is simple,time-sav-ing,specific,reproducible,accurate and reliable,and can be used for the quality control of Tobramycin and dexamethasone eye drop.