建立了测定磺胺甲噁唑原料药的残留溶剂测定方法.以检测器为FID检测器,色谱柱使用Agilent DB-WAX毛细管色谱柱,顶空进样测试,采用内标法计算残留溶剂的含量.对方法进行了系统的方法学验证,专属性、线性范围、准确度、精密度、检出限、定量限、耐用性、溶液稳定性完全能够满足检测要求.本法灵敏、准确、快速,适用于磺胺甲噁唑原料药的残留溶剂检测.
A headspace gas chromatography method was developed for the determination of residual solvents in sulfamethoxazole, The flame ionization detector and DB-WAX capillary column were used for the separation and detection of the residual solvents. The internal standard method could be used for quantification. The developed method was systematically verified that the specificity, linearity, accuracy, precision, limit of detection, limit of quantification, robustness, and solution stability met the criteria. The proposed method could be applied in the determination of residual solvents in sulfamethoxazole with the advantages of high sensitivity, rapidity, and simplicity.