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.

1.王明, 周永芳, 张哲铭, 等. 三乙酸甘油酯合成中催化剂与能耗的关键技术[J]. 塑料, 2023, 52(1): 5-9.[Wang M, Zhou YF, Zhang ZM, et al. Key technologies of catalysts and energy consumption in synthesis of bio-based triacetin[J]. Plastics, 2023, 52(1): 5-9.] http://qikan.cqvip.com/Qikan/Article/Detail?id=7109083756.

2.中国药典2020年版. 四部[S]. 2020: 634.

3.EP11. 0[S]. 2021: 4265.

4.USP现行版[S]. 2023.

5.BP2023[S]. 2023: 5421.

6.陈名清, 刘灿, 唐宝强, 等. 顶空气相色谱法测定15-羟基硬脂酸聚乙二醇酯中环氧乙烷和二氧六环含量[J]. 中国药品标准, 2023, 24(2): 205-211. [Chen MQ, Liu C, Tang BQ, et al. Determination of ethylene oxide and dioxane in 15-hydroxystearic acid polyethylene glycol ester by headspace gas chromatography[J]. Drug Standards of China, 2023, 24(2): 205-211.] DOI: 10.19778/j.chp.2023.02.017.

7.李浩宇, 唐宝强, 何东升, 等. 气相色谱法测定药用辅料聚西托醇1 000中的残留杂质[J]. 中国药科大学学报, 2022, 53(3): 293-299. [Li HY, Tang BQ, He DS, et al. Determination of residual impurities in pharmaceutical excipient cetomacrogol 1 000 by gas chromatography[J]. Journal of China Pharmaceutical University, 2022, 53(3): 293-299.] DOI: 10.11665/j.issn.1000-5048.20220306.

8.陈子龙, 路京, 赵丽, 等. 毛细管气相色谱法同时测定盐酸妥洛特罗原料的残留溶剂、杂质与含量[J]. 中南药学, 2021, 19(10): 2154-2157. [Chen ZL, Lu J, Zhao L, et al. Simultaneous determination of residual solvents, impurity and content in tulobuterol hydrochloride by capillary gas chromatography[J]. Central South Pharmacy, 2021, 19(10): 2154-2157.] DOI: 10.7539/j.issn.1672-2981.2021.10.029.

9.方欣欣, 严翠霞, 梅妮, 等. 凝胶渗透色谱法同时测定山嵛酸甘油酯中单、二、三甘油酯和游离甘油含量[J]. 中国药品标准, 2023, 24(1): 20-24. [Fang XX, Yan CX, Mei N, et al. Simultaneous determination of mono, di- and triglyceride and free glycerol content in glyceryl behenate by gel permeation chromatography[J]. Drug Standards of China, 2023, 24(1): 20-24.] DOI: 10.19778/j.chp.2023.01.003.

10.廉贞霞, 李霞, 姜鹰雁, 等. 气相色谱法测定N,N-二异丙基乙胺中的有关物质[J]. 食品与药品, 2023, 25(6): 520-523. [Liang ZX, Li X, Jiang YY, et al. Determination of related substances in N,N-di isopropyl ethylamine by gas chromatography[J]. Food and Drug, 2023, 25(6): 520-523.] DOI: 10.3969/j.issn.1672-979X.2023.06.007.

11.王辉, 帅海涛, 唐璐强, 等. 气相色谱法测定高级脂肪醇中的有关物质[J]. 当代化工, 2023, 52(1): 243-247. [Wang H, Shuai HT, Tang LQ, et al. Determination of related substances in higher fatty alcohol by GC[J]. Contemporary Chemical Industry, 2023, 52(1): 243-247.]  DOI: 10.3969/j.issn.1671-0460.2023.01.051.

12.谢婷, 伍鸣亮, 曾海金, 等. 气相色谱法测定环丙甲酸中有关物质的方法学研究[J]. 山东化工, 2022, 51(21): 147-150, 157. [Xie T, Wu ML, Zeng HJ, et al. GC analysis and methodology research for related substance in cyclopropanecarboxylic acid[J]. Shandong Chemical Industry, 2022, 51(21): 147-150, 157.] DOI: 10.3969/j.issn.1008-021X.2022.21.043.