Quality and Safety Evaluation of Antibacterial Agents in Aciclovir Eye Drops Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.09.005
- VernacularTitle:基于国家药品抽检的阿昔洛韦滴眼液抑菌剂质量安全评价
- Author:
Weiwei JIA
1
;
Weifeng DU
1
;
Xinghong WEI
1
;
Yi LIU
1
;
Zili XIE
1
Author Information
1. 安徽省食品药品检验研究院化学药品检验室,合肥 230051
- Publication Type:Journal Article
- Keywords:
Aciclovir eye drops;
Antibacterial agents;
High performance liquid chromatography;
Quality and safety evaluation;
National drug sampling and testing
- From:
Herald of Medicine
2025;44(9):1400-1404
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a high-throughput HPLC method for the simultaneous determination of 11 common antibacterial agents in acyclovir eye drops and to evaluate the quality and safety of the antibacterial agents in 42 batches of national drug inspection samples.Methods Gradient elution was performed on a Kromasil 100-5-C18(4.6 mm×250 mm,5 μm)column with acetonitrile-5 mmol·L-1 ammonium acetate aqueous solution(containing 1%triethylamine,pH adjusted to 4.5 by acetic acid)as the mobile phase.The detection wavelength was 262 nm.Results Good linear relationships were obtained for 11 antibacterial agents(r≥0.999 9).The average recovery range was 98.2%-101.8%,and the RSD was 0.7%-2.7%(n=9).As revealed by the systematic analysis of 42 batches of national drug inspection samples,some batches of samples were detected with out-of-prescription antibacterial agents 4-hydroxybenzoic acid and ethylparaben,and the results were 0.02-49 μg·mL-1.This indicated that ethylparaben degradation and colinear production pollution were the two major risk sources.Conclusions The method is accurate,sensitive,and specific and can be used for the qualitative and quantitative detection of antibacterial agents in acyclovir eye drops.Besides,some products have degradation of antibacterial agents and incomplete cleaning during co-linear production.It is still essential to further reinforce product quality control.
