Determination of alcohol and phenolic antibacterial agents in eye drops by gas chromatography
10.19778/j.chp.2025.02.012
- VernacularTitle:气相色谱法测定滴眼剂中醇酚类抑菌剂的含量
- Author:
Jing LIU
1
;
Qing GAO
;
Hong JI
;
Jing GAO
;
Dan HU
;
Wei WANG
Author Information
1. 北京市药品检验研究院,北京 102206
- Publication Type:Journal Article
- Keywords:
chlorobutanol;
eye drops;
antibacterial agents;
gas chromatography
- From:
Drug Standards of China
2025;26(2):198-202
- CountryChina
- Language:Chinese
-
Abstract:
Objective:A gas chromatographic method was established for the determination of alcohol and phenolic bacteriostatic agents(chlorobutanol,phenol,benzyl alcohol,phenethyl alcohol,phenoxyethanol,4-chloro-o-cresol and thymol)in eye drops for related quality control.Methods:A capillary column with(5%phenyl)methylsilox-ane as the fixing solution.The initial temperature was 60℃and keep for 10 min.The temperature was rised to 150℃at a rate of 20℃·min-1 and keep for 3 min,Next,the temperature was rised to 230℃at a rate of 50℃·min-1 and keep for 2 min.The detector temperature was 250℃,the inlet temperature was 200℃,and the detector was FID.Direct injection of 1 μL was used for injection.Results:The were a good linear relationship between peak area and concentration in the concentration range of 0.05-1.0 mg·mL-1(chlorobutanol),0.05-1.0 mg·mL-1(phenol),0.1-2.0 mg·mL-1(benzyl alcohol),0.05-1.0 mg·mL-1(phenethyl alco-hol),0.05-1.0 mg·mL-1(phenoxyethanol),0.03-0.6 mg·mL-1(4-chloro-o-cresol)and 0.01-0.20 mg·mL-1(thymol)(r values were 0.999 7,0.999 6,0.999 5,0.999 5,0.999 5,0.999 5,0.999 5 and 0.999 5 respectively).The average recoveries of seven component were 103.4%,95.2%,98.4%,97.2%,97.9%,100.5%and 93.5%respectively.All meet the requirements of methodological research.According to the method,79 batches of samples were tested for alcohol and phenolic bacteriostatic agents.Chlorobutanol was detected in 8 batches of samples,and no other bacteriostatic agents were detected.Conclusion:This method meets the require-ments for specificity and sensitivity,and is suitable for the confirmation and determination of alcohol and phenolic antibacterial agents in eye drops.It can be used for related quality control.
