顶空气相色谱法测定克林霉素磷酸酯中残留甲醇、乙醇、丙酮、吡啶的含量  

Determination of Residual Methanol,Ethanol,Acetone and Pyridine in Clindamycin Phosphate by Headspace Gas Chromatography

作　　者：许佼 杨娟[2] 赵向阳 XU Jiao;YANG Juan;ZHAO Xiang-yang(Food and Drug Inspection and Testing Center of Suzhou City,Suzhou 234000,China;First People′s Hospital of Suzhou City,Suzhou 234000,China)

机构地区：[1]宿州市食品药品检验检测中心,安徽宿州234000 [2]宿州市第一人民医院,安徽宿州234000

出　　处：《海峡药学》2020年第1期62-65,共4页Strait Pharmaceutical Journal

摘　　要：目的建立同时测定克林霉素磷酸酯中甲醇、乙醇、丙酮和吡啶的残量检测方法,并对某公司所生产的原料药进行残留量测定。方法采用顶空气相色谱法,FID检测器,采用程序升温,FID检测器温度为250℃,载气为氮气,流速为2mL·min^-1,分流比为4∶1。结果3批样品中甲醇、乙醇、丙酮和吡啶4种有机溶剂残留量均符合要求。结论顶空气相色谱法灵敏、准确、可靠,适合于克林霉素磷酸酯中有机溶剂残留量的测定,且公司所产原料药中溶剂残留均符合国家规定。OBJECTIVE To establish the determine residual organic solvent volume in clindamycin phosphate by headspace gas chromatography,the residual amount of the clindamycin phosphate produced by the company A was determined.METHODS The determination was performed on DB-624(30m×0.53mm,3μm)capillary column with temperature programming.The detector temperature was 250℃with the nitrogen carrier gas.The flow rate was 2mL·min^-1 and the split ratio was 4∶1.RESULTS The contents of four residual organic solvents in three batches of samples complied with the specification requirements.CONCLUSION The method is proved to be sensitive accurate and reliable.It is suitable to be adopted in the analysis of testing the residual organic solvent in clindamycin phosphate.In addition,the solvent residues in the company′s drugs meet pharmacopoeia standards.

关 键 词：顶空气相色谱法 克林霉素磷酸酯 有机残留溶剂 

分 类 号：R927[医药卫生—药学]