CAJ | 학술논문

目的：建立药品包材中残留溶剂的含量测定方法。方法：色谱柱为 DM－WA（30 mm ×0.25 mm ×0.25μm）；程序升温，30℃保持10 min，以10℃／min 上升至90℃，保持2 min，以90℃／min 上升至160℃，保持5 min；进样口温度160℃；氢焰离子化检测器，温度220℃；以正己烷为内标定量。结果：丙酮、乙酸乙酯、丁酮、异丙醇、苯、甲苯的回归方程分别为 Y ＝3.5638X ＋0.0120，Y ＝3.6619X ＋0.0099，Y ＝4.9390X ＋0.0104，Y ＝3.7315X ＋0.0042，Y ＝10.112X ＋0.0291，Y ＝10.258X ＋0.0370。蒙脱石散包材残留溶剂为甲苯，平均回收为97.2％，RSD ＝1.41％。结论：该方法准确、重现性好、灵敏度高，可用于药品包材残留溶剂的含量测定。
목적：건립약품포재중잔류용제적함량측정방법。방법：색보주위 DM－WA（30 mm ×0.25 mm ×0.25μm）；정서승온，30℃보지10 min，이10℃／min 상승지90℃，보지2 min，이90℃／min 상승지160℃，보지5 min；진양구온도160℃；경염리자화검측기，온도220℃；이정기완위내표정량。결과：병동、을산을지、정동、이병순、분、갑분적회귀방정분별위 Y ＝3.5638X ＋0.0120，Y ＝3.6619X ＋0.0099，Y ＝4.9390X ＋0.0104，Y ＝3.7315X ＋0.0042，Y ＝10.112X ＋0.0291，Y ＝10.258X ＋0.0370。몽탈석산포재잔류용제위갑분，평균회수위97.2％，RSD ＝1.41％。결론：해방법준학、중현성호、령민도고，가용우약품포재잔류용제적함량측정。
Objective:To establish a standard method for the determination of residual solvents in pharmaceutical packaging mate-rials.Methods:Gas chromatography was performed with chromatographic column of DM - WAX (30 mm ×0.25 mm ×0.25μm)and the temperatures of injection port and hydrogen flame ionization detector were set at 160 ℃ and 220 ℃ respectively. Temperature programme:the column temperature rose to 30 ℃ and hold for 10 mins;rose by 10 ℃ per minute from 30 ℃ to 90℃,and hold for 2 minutes,then by 90 ℃ per minute to 160 ℃ and hold for 5 minutes.n-hexane was the internal standard when determinating the content of residual solvents in different pharmaceutical packaging materials.Results:Acetone,ethyl acetate,bu-tanone,isopropyl alcohol,benzene,toluene regression equations were Y =3.5638X +0.0120,Y =3.6619X +0.0099,Y =4.9390X+0.0104,Y =3.7315X +0.0042,Y =10.112X +0.0291,Y =10.258X +0.0370 respectively.The residual solvents in Mont-morillonite powder packaging material is toluene,the average recovery is 97.2%,RSD =1.41%.Conclusion:The method is accu-rate,reproducible,high sensitivity,and can be used for the determination of residual solvents in pharmaceutical packaging materials.