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建立了倍他米松中溶剂残留量的分离测定方法。采用气相色谱法,以氮气为载气,FID检测器,KB-5毛细管柱,程序升温,外标法测定倍他米松中甲醇、丙酮、二氯甲烷和甲苯及N,N-二甲基甲酰胺的残留量。5种有机溶剂完全分离,在所考察的浓度范围内具有良好的线性,r=0.999 4~0.999 9,平均回收率97.48%~102.24%,精密度RSD小于5%,检测限0.03~0.10μg/mL。所建立的方法快速、灵敏、准确,可用于倍他米松中有机溶剂残留量的测定。
A method for the separation and determination of solvent residues in betamethasone was established. Gas chromatography was used to determine methanol, acetone, methylene chloride and toluene and N, N-dimethyl formamide in betamethasone with nitrogen gas as carrier gas, FID detector, KB-5 capillary column, programmed temperature and external standard method Amide residue. The average recoveries were 97.48% ~ 102.24%, the RSDs of precision were less than 5%, and the detection limits were 0.03 ~ 0.10μg / mL. The established method is rapid, sensitive and accurate and can be applied to the determination of organic solvent residues in betamethasone.