顶空气相色谱法测定克林霉素磷酸酯中有机溶剂残留量

Determination of Residual Organic Solvents in Clindamycin Phosphate by Headspace Gas Chromatography

目的测定克林霉素磷酸酯中甲醇、乙醇、丙酮、三氯甲烷和吡啶的残留量。方法采用毛细管气相色谱法,DB-624毛细管柱(30m×0.53mm,3μm),FID检测器,柱温采用程序升温,FID检测器温度为250℃,载气为氮气,流速为3mL/min,分流比为1:1。结果3批样品中5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。

Objective To determine residual organic solvent volume in clindamycin phosphate by headspace gas chromatography. Methods The determination was performed on DB- 624（30 m × 0. 53 mm, 3 μm） capillary column with temperature programming, the detector temperature was 250 ℃, the carrier gas was nitrogen, the flow rate was 3 mL/min and the split ratio was 1 ： 1. Results The contents of five 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 elindamycin phosphate.