Determination of fatty acid compositions in hydrogenated palm glycerides by gas chromatography
10.19778/j.chp.2024.05.013
- VernacularTitle:气相色谱法测定氢化棕榈油甘油酯的脂肪酸组成
- Author:
Xinao LIU
1
,
2
;
Zhihao LIU
;
Li YIN
;
Zhengyu LIU
;
Chunmeng SUN
;
Jiasheng TU
Author Information
1. 中国药科大学药学院药用辅料及仿创药物研发评价中心
2. 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,南京 210009
- Keywords:
hydrogenated palm glycerides;
fatty acid composition;
gas chromatography;
pharmaceutical excipi-ents;
quality standards;
area normalization method
- From:
Drug Standards of China
2024;25(5):506-511
- CountryChina
- Language:Chinese
-
Abstract:
Objective:A gas chromatography analysis system for fatty acid compositions of hydrogenated palm glycerides was established to provide a reference for quality standards of hydrogenated palm glycerides.Methods:In this test,a DB-WAX(30 m ×0.53 mm,1.0 μm)strong polarity gas chromatographic column was employed with an injection volume of 1 μL and a split ratio of 120∶1.The initial column temperature was 70℃,sustained for 2 min,ramped up to 230 ℃ at a rate of 5 ℃ per minute,and maintained for 10 min,with the inlet temperature of 250 ℃ and the detector temperature of 250 ℃.Results:In this experiment,the gas chromatograph-ic method was established successfully to determine fatty acid compositions of hydrogenated palm glycerides.The validated results indicated that the method exhibited well-suited system applicability,specificity and precision,and the RSD(％)fulfilled the requirements.The limit of detection(LOD)and limit of quantification(LOQ)values of nine fatty acid methyl esters were defined,and fatty acid compositions of seven batches of samples were checked successfully.Conclusion:The GC methodology developed in this study is suitable for the analysis and determina-tion of fatty acid compositions in hydrogenated palm glycerides,which can serve as a reference for the quality control of this pharmaceutical excipient and the establishment of quality standards.
