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目的:建立毛细管气相色谱法测定马来酸桂哌齐特中三氯甲烷残留量的方法。方法:色谱柱为HP-1701石英毛细管柱,柱温采用程序升温,检测器为ECD检测器,检测器温度为250℃,进样口温度为200℃,以N,N-二甲基甲酰胺为溶剂。结果:三氯甲烷的检测浓度的线性范围为2.4～120mg.L-1(r=0.9999);平均回收率为99.4%(RSD=1.2%);最低检出限为0.36pg;3批样品中三氯甲烷残留量均符合《中国药典》要求。结论:本方法简单、准确、灵敏度高、重现性好,可用于该药物中三氯甲烷残留量的测定。
Objective: To establish a method for the determination of trichloromethane in cinepazide maleate by capillary gas chromatography. Methods: The column was HP-1701 quartz capillary column. The temperature of the column was raised by programmed temperature. The detector was ECD detector. The temperature of the detector was 250 ℃ and the temperature of the inlet was 200 ℃. Using N, N-dimethylformamide As a solvent. Results: The linear range of the concentration of trichloromethane was 2.4 ~ 120mg.L-1 (r = 0.9999). The average recovery was 99.4% (RSD = 1.2%). The minimum detectable limit was 0.36pg. Trichloromethane residues are in line with the “Chinese Pharmacopoeia” requirements. Conclusion: The method is simple, accurate, sensitive and reproducible. It can be used for the determination of trichloromethane residues in the drug.