CAJ | 학술논문

目的：建立气相色谱法（GC 法）测定注射用聚山梨酯80中脂肪酸组成。方法采用直接进样 GC 法，色谱柱为DB-WAX 毛细管柱，检测器为 FID，载气为氮气，柱温250℃。结果注射用聚山梨酯80中8种脂肪酸衍生的脂肪酸甲酯（肉豆蔻酸甲酯、棕榈酸甲酯、硬脂酸甲酯、油酸甲酯、亚油酸甲酯、花生酸甲酯、二十碳烯酸甲酯、山嵛酸甲酯）均呈现良好的线性关系，精密度、重复性 RSD 均＜3%，加样回收率在96.5%~104.2%。结论本法方法简便、灵敏、准确、重现性好，适用于注射用聚山梨酯80的质量控制。
목적：건립기상색보법（GC 법）측정주사용취산리지80중지방산조성。방법채용직접진양 GC 법，색보주위DB-WAX 모세관주，검측기위 FID，재기위담기，주온250℃。결과주사용취산리지80중8충지방산연생적지방산갑지（육두구산갑지、종려산갑지、경지산갑지、유산갑지、아유산갑지、화생산갑지、이십탄희산갑지、산유산갑지）균정현량호적선성관계，정밀도、중복성 RSD 균＜3%，가양회수솔재96.5%~104.2%。결론본법방법간편、령민、준학、중현성호，괄용우주사용취산리지80적질량공제。
Objective To determine the contents of fatty acids in polysorbate 80 for injection by GC. Methods The GC system consisted of DB-WAX capillary column and the temperature was set at 250℃. The detector was FID using nitrogen as carrier gas. Results The fatty acid methyl esters (methyl myristate, methyl palmitate, methyl stearate, methyl oleate, methyl linoleate, methyl arachidate, methyl eicosenoate, methyl behenate) were separated with a good linearity in the sample size ranges. The average recoveries were 96.5%~104.2%. Conclusion This method is simple, feasible and reproducible. It can be used for the quality control of polysorbate 80 for injection.