Determination of related substances in the pharmaceutical excipient triacetin by gas chromatography
10.12173/j.issn.1008-049X.202312007
- VernacularTitle:气相色谱法测定药用辅料甘油三乙酯的有关物质
- Author:
Yue ZHANG
1
;
Rong SHI
;
Jinfeng ZHENG
;
Yanming LIU
;
Yingying XIE
;
Ying LI
Author Information
1. 湖南省药品检验检测研究院(长沙 410001);国家药品监督管理局药用辅料工程技术研究重点实验室(长沙 410001)
- Keywords:
Triacetin;
Gas chromatography;
Related substances;
Pharmaceutical excipients
- From:
China Pharmacist
2024;27(2):227-232
- CountryChina
- Language:Chinese
-
Abstract:
Objective To determine the related substances in the pharmaceutical excipient triacetin by gas chromatography(GC).Methods Rtx-1701 and DB-1701 chromatographic column(30 m×0.25 mm,0.25 μm)was used,with nitrogen as the carrier gas,the flow rate was 1.5 mL/min,the inlet temperature was 200℃,the hydrogen flame ionization detector was used,the temperature of the measuring instrument was 250℃,and the program heating was used.Results Under this chromatographic condition,each substance could be effectively separated,and showed good linearity at 2-40 μg/mL(r>0.99).The recovery rates of acetic acid,glycerol,1-monoglyceryl acetate,1,2-diglyceryl acetate and 1,3-diglyceryl acetate were 100.7%(RSD=3.12%),95.1%(RSD=3.66%),99.43%(RSD=4.62%),103.66%(RSD=5.88%)and 103.15%(RSD=4.17%)(n=6),respectively.Conclusion This method has high accuracy and good reproducibility,which can be used for the determination of related substances in the triacetin,and provides a reference for the quality standard of triacetin.
