Optimization of gas chromatographic method for the determination of residual benzene content in carbomers
10.19778/j.chp.2024.04.013
- VernacularTitle:卡波姆系列药用辅料中苯残留的气相色谱测定方法的优化
- Author:
Qinying CHEN
1
;
Yerong XIONG
;
Zuoxun FENG
;
Dongsheng HE
;
Chunmeng SUN
;
Jiasheng TU
Author Information
1. 国家药品监督管理局药物制剂及辅料研究与评价重点实验室,中国药科大学,南京 210009
- Keywords:
carbomer;
benzene;
gas chromatography;
quality standards;
residual solvents;
pharmaceutical excipients
- From:
Drug Standards of China
2024;25(4):398-404
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop and validate gas chromatographic methods for the determination of residual benzene in carbomer copolymer,carbomer homopolymer and carbomer interpolymer,to address the issues of the current method in the Chinese Pharmacopoeia in the actual detection process,such as low sensitivity and poor repeatability of benzene detection in the mixed reference solution,and to optimize and improve the current stand-ards for series of carbomer pharmaceutical excipients.Methods:Samples were separated on a column DB-624(30 m ×0.530 mm,3.00 μm)with temperature programming,the inlet temperature of 140 ℃,the detector tem-perature of 250 ℃,and the split ratio of 5∶1.The external standard method was adopted for the quantitative deter-mination of residual benzene.Results:The linearity was great across the range of 0.04-1.00 μg·mL-1(r=0.996 8),the injection precision of benzene was 6.8％(n=6),and the average recovery rate was 96.89％(RSD=8.1％,n=9).Conclusion:The gas chromatographic method established in this research is more specif-ic,with higher accuracy and precision compared to the current method in the Chinese Pharmacopoeia.This optimized method is more suitable for the determination of residual benzene content in carbomer copolymer,car-bomer homopolymer and carbomer interpolymer,providing reference and guidance for the quality management and the control of carbomer.
