Optimization of determination method for residual solvents of esmolol hydrochloride
10.19778/j.chp.2024.02.007
- VernacularTitle:盐酸艾司洛尔残留溶剂测定方法优化
- Author:
Siming CHEN
1
;
Xiankun WENG
;
Haiyun SUN
;
Zongyu LUO
Author Information
1. 海南省食品药品检验所五指山分所,海南五指山 572299
- Keywords:
esmolol hydrochloride;
residual solvents;
headspace injection;
method optimization;
capillary gas chromatography;
methodological validation
- From:
Drug Standards of China
2024;25(2):154-158
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To optimize the detection method for residual solvents of esmolol hydrochloride for control of internal quality.Methods:Gas chromatography headspace injection method was adopted by selecting appropriate headspace equilibrium temperature and time in order to reduce sample contamination of the instrument,optimizing solvent ratio for reducing matrix effect and adjusting carrier gas flow rate and split ratio.Polar capillary column pro-grammed temperature rise method was used with high temperature holding time,etc.,and methodological validation was conducted.Results:Ether,ethyl acetate,methanol,and toluene could all be effectively separated with good precision,and there were good linear relationships between peak areas and mass concentrations.The accuracy of sample spiking at 50％,100％,and 150％concentrations was investigated,and the average recovery rates could all reach ranges of 94.8％-105.6％.Conclusion:This method is accurate,highly sensitive,and overcomes the shortcomings of the Chinese Pharmacopoeia methods.It can be used for the detection of residual solvents in esmolol hydrochloride.
