HPLC method for the simultaneous determination of hydroxyphenyl esters and quaternary ammonium bacteriostatic agents in eye drops
10.19778/j.chp.2024.03.004
- VernacularTitle:HPLC法同时测定滴眼剂中羟苯酯类和季铵盐类抑菌剂含量的方法研究
- Author:
Jin GAO
1
;
Dan HU
;
Yi BAO
;
Xiaocui YU
;
Zexin WANG
;
Jing LIU
;
Guiying ZHANG
;
Yingying ZHAO
;
Zhenyu CAO
;
Chunpu LI
;
Xiaoxu HONG
Author Information
1. 中国人民解放军联勤保障部队药品仪器监督检验总站,北京 100071
- Keywords:
eye drops;
hydroxyphenyl ester;
quaternary ammonium;
HPLC;
bacteriostatic agent
- From:
Drug Standards of China
2024;25(3):234-243
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a general method for the simultaneous determination of hydroxyphenyl esters and quaternary ammonium bacteriostatic agents in eye drops.Methods:The chromatographic analysis was per-formed on an Agilent C18 column(4.6 mm ×250 mm,5 μm)with 1％triethylamine solution(pH adjusted to 5.0 with phosphoric acid)as mobile phase A and methanol as mobile phase B.Gradient elution was performed at col-umn temperature of 40 ℃.The detection wavelength was 214 nm,the flow rate was 1 mL·min-1,and the injec-tion volume was 20 μL.Results:Methylparaben,ethylparaben,propylparaben,butylparaben,benzalkonium chlo-ride and benzalkonium bromide were 0.11-559.0,0.10-513.0,0.10-258.8,0.11-270.5,1.07-537.0 and 1.03-512.8 μg·mL-1,respectively.The linear range was good(r＞0.999).The average recoveries of meth-ylparaben,benzalkonium bromide and benzalkonium chloride were 104.7％(RSD=1.3％),102.6％(RSD=1.1％)and 100.9％(RSD=1.1％),respectively.The contents of bacteriostatic agent in 100 batches of eye drops from 36 varieties of 12 enterprises were determined,and the accurate results were obtained.Conclusion:This meth-od provides a reference for the content quality control and safety evaluation of bacteriostatic agents in eye drops.
