顶空气相色谱法测定盐酸二甲双胍中的残留溶剂

Determination of Residual Solvents in Metformin Hydrochloride by Head-space GC

目的建立顶空气相色谱法测定盐酸二甲双胍中的残留溶剂。方法Ⅰ以DB-624毛细管柱为色谱柱;程序升温;FID检测器;顶空进样。结果在此色谱条件下,甲醇、甲苯、N,N-二甲基甲酰胺残留分析专属性、线性、精密度、准确度良好。结论经过方法学验证,该方法适用于盐酸二甲双胍中甲醇、甲苯及N,N-二甲基甲酰胺的残留测定。方法Ⅱ以DB-1毛细管柱为色谱柱;程序升温;FID检测器;顶空进样。结果在此色谱条件下,苯残留分析专属性、线性、精密度、准确度良好。结论经过方法学验证,该方法适用于盐酸二甲双胍中苯的残留测定。

Objective To establish method for determination of residual solvents in metformin hydrochloride. Method ⅠMethods A DB-624 column(temperature programming), FID and head-space were used. Results Methanol, toluene and N,N-dimethylaniline showed good specificity, linearity, precision and accuracy. Conclusion Method I is suitable for the determination of methanol, toluene and N,N-dimethylaniline in metformin hydrochloride through the methodology validation. Method ⅡMethods A DB-1 column(temperature programming),FID and head-space were used. Results Benzene showed good specificity, linearity, precision and accuracy. Conclusion Method Ⅱ is suitable for the determination of benzene in metformin hydrochloride through the methodology validation.