中国药品标准2024,Vol.25Issue(5) :506-511.DOI:10.19778/j.chp.2024.05.013

气相色谱法测定氢化棕榈油甘油酯的脂肪酸组成

Determination of fatty acid compositions in hydrogenated palm glycerides by gas chromatography

刘馨澳 刘智昊 殷丽 刘正宇 孙春萌 涂家生
中国药品标准2024,Vol.25Issue(5) :506-511.DOI:10.19778/j.chp.2024.05.013

气相色谱法测定氢化棕榈油甘油酯的脂肪酸组成

Determination of fatty acid compositions in hydrogenated palm glycerides by gas chromatography

刘馨澳 1刘智昊 1殷丽 1刘正宇 1孙春萌 1涂家生1
扫码查看

作者信息

  • 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;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
  • 折叠

摘要

目的:构建一种利用气相色谱法的氢化棕榈油甘油酯脂肪酸组成分析体系,为药用辅料氢化棕榈油甘油酯的质量标准制定提供参考依据.方法:选用DB-WAX(30 m ×0.53 mm,1.0 μm)强极性气相色谱柱,进样体积1 μL,分流比为120∶1,起始柱温70 ℃,维持2 min,以每分钟5℃的速率升温至230℃,维持10 min,进样口温度250 ℃,检测器温度为250℃.结果:本实验成功建立了一种气相色谱方法来测定氢化棕榈油甘油酯的脂肪酸组成,验证结果显示该方法具有良好的系统适用性、专属性和精密度,RSD(%)满足要求,确定了 9种脂肪酸甲酯的检测限和定量限,并成功对7批样品进行脂肪酸成分考察.结论:本试验开发的气相色谱法,适用于氢化棕榈油甘油酯中脂肪酸组成的分析测定,能够为该药用辅料的质量控制和质量标准的设立提供参考依据.

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.

关键词

氢化棕榈油甘油酯/脂肪酸组成/气相色谱法/药用辅料/质量标准/面积归一化法

Key words

hydrogenated palm glycerides/fatty acid composition/gas chromatography/pharmaceutical excipi-ents/quality standards/area normalization method

引用本文复制引用

出版年

2024
中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
段落导航相关论文