气相色谱法测定替莫唑胺中溶媒残留量  

Determination of solvent residue in Temozolomide by gas chromatography

作　　者：刘虹[1] 任晓明[2] 张福义[3] 

机构地区：[1]郑州大学分析测试中心,郑州450052 [2]信阳教育学院生物学化学系,信阳464000 [3]郑州大学化学系,郑州450052

出　　处：《郑州大学学报（医学版）》2004年第2期312-314,共3页Journal of Zhengzhou University(Medical Sciences)

摘　　要：目的:测定替莫唑胺中残留溶媒丙酮、乙酸乙酯的含量。方法:采用程序升温气相色谱法,检测3批替莫唑胺原料药中残留溶媒丙酮、乙酸乙酯含量。结果:该法检测丙酮、乙酸乙酯的线性范围分别为1.9-38.0 mg/L、2.05～41.00 mg/L,线性回归方程分别为Y=150.36c+46.305、y=163.84c-18.869,相关系数分别为0.999 6、0.999 4,最低检出浓度分别为0.95 mg,/L、1.00 mg,/L,RSD分别为0.6％、0.9％。3批样品丙酮含量0.059％-0.067％,未检出乙酸乙酯,回收率分别为98.4％-102.6％、97.5％～103.2％。结论:该方法简便、快速、准确,适用于替莫唑胺中溶媒残留量的测定。Aim : Determine the contents of the solvents residues acetone、ethyl acetate in temozolomide. Methods: Gc was applied to quantitative analysis. GDX-103( 177 -250 μm) column(2 m×2.6 mm)and hydrogen flame ionization detector were selected. Results:The linear ranges of acetone and ethyl acetate were 1.9 - 38.0 mg/L, 2.05 - 41.00 mg/ L, respectively; the regression equation were Y=150.36c+ 46.305 ,Y = 163. 84c - 18. 869;the correlative coefficient were r=0.9996, r=0.9994; the limits of detection of acetone and ethyl acetate were 0.95 mg/L, 1.00 mg/L;the RSD were 0.6% ,0.9% respectively; the recoveries were 98. 4% - 102. 6% , 97. 5% - 103. 2% respectively. Conclusion: This method was simple, rapid and accurate. It was quite suitable to be used in analysis of the solvents residues in temozolo- mide.

关 键 词：气相色谱法 替莫唑胺 溶媒残留量 丙酮 乙酸乙酯 

分 类 号：O657.7[理学—分析化学]