摘要
目的 建立气相色谱(GC)法测定药用辅料甘油三乙酯的有关物质.方法 采用Rtx-1701 和DB-1701 色谱柱(30 m×0.25 mm,0.25 μm),载气为氮气,流速为1.5 mL/min,进样口温度为200℃,采用氢火焰离子化检侧器,检测器温度为250℃,程序升温.结果 在该色谱条件下,各物质能有效分离,在 2～40 μg/mL范围内线性关系良好(r＞0.99).乙酸、甘油、1-单乙酸甘油酯、1,2-二乙酸甘油酯及 1,3-二乙酸甘油酯回收率分别为100.7%(RSD=3.12%)、95.1%(RSD=3.66%)、99.43%(RSD=4.62%)、103.66%(RSD=5.88%)、103.15%(RSD=4.17%)(n=6).结论 本方法准确度高、重现性好,可用于甘油三乙酯有关物质的测定,为完善其质量标准提供依据.
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.
基金项目
湖南省自然科学基金科药联合基金项目(2023JJ60106)
维普
万方数据