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气相色谱法测定辛伐他汀中的8种残留溶剂 被引量:10

GC determination of 8 kinds of residual solvents in simvastatin
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摘要 目的:用毛细管色谱柱气相色谱方法建立8种残留溶剂的测定方法。方法:采用 DB-Wax(30 m×0.53 mm×1.00μm)毛细管柱,以氮气为载气,FID 检测,2次程序升温,直接进样,测定残留溶剂的含量。结果:在各自的浓度范围内具有良好的线性关系(所测试的8种溶剂的相关系数均为0.999以上),8种溶剂的3个浓度的平均回收率范围均在91.0%~106.2%,RSD 为2.2%~5.2%。结论:本方法简便,结果准确,重现性好,可用于多种残留溶剂的同时测定。 Objective: To establish a method for determination of the residues of 8 kinds of solvents by capillary gas chromatography. Method:The capillary column was DB -Wax (30 m × 0. 53 mm × 1.00 μm). The carrier gas was nitrogen and FID as detector. The injector temperature was 200 ℃, and the detector temperature was 250 ℃. The initial column temperature was kept at 34 ℃ for 4min with an increase rate of 10 ℃ · min^-1 to 60 ℃ ,then 50 ℃ · min^-1 to 160 ℃ (sustained for 5 min). The quantification of residual solvents was calculated by external standard method. Results:Under the above condition, there was good linear relationship in the concentration range measured, the recoveries and RSDs ranged from 91.0% to 106.2% and 2.2% to 5.2% ,respectively. Conclusion:The method is simple accurate and reproducible.
出处 《药物分析杂志》 CAS CSCD 北大核心 2007年第1期148-150,共3页 Chinese Journal of Pharmaceutical Analysis
关键词 气相色谱法 辛伐他汀 毛细管柱 残留溶剂 gas chromatography simvastatin capillary column residual solvent
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