关键词: 三磷酸胞苷二钠, 残留溶剂, 检测方法, 气相色谱-质谱联用（GC-MS）

Abstract:

Objective： To establish a detection method for residual solvents in cytidine disodium triphosphate.Methods： Agilent J&W DB-624UI （60 m×0.25 mm×0.25 μm） was used as the chromatographic column. The injection port temperature was 250 ℃. The column temperature was programmed to rise （initial temperature 40 ℃， maintained for 10 min， rising to 80 ℃ at a rate of 5 ℃•min^-1， then rising to 220 ℃ at a rate of 12 ℃•min^-1 and maintained for 3 min）. Carrier gas： helium， flow rate 1 mL•min^-1， split injection， split ratio： 10∶1. Headspace incubator equilibrium temperature： 85 ℃. Equilibrium time： 30 min； electron impact （EI） ion source； transmission line temperature： 250 ℃， ion source temperature： 230 ℃. Quadrupole temperature： 150 ℃， electron energy： 70 eV. The established method was verified for specificity， linearity， accuracy， precision， and repeatability， and the detection limit and quantification limit of the method were established.Results： Using the established method to determine the residual solvent contents in more than 30 batches of samples. Residual ethanol was detected in 5 batches of samples.Conclusion： The developed GC-MS method is simple， precise， stable， accurate and specific and can be used for quality control of cytidine disodium triphosphate.

Key words:  , Cytidine disodium triphosphate； , Residual solvents； , Detection method； , Gas chromatography-mass spectrometry , （GC-MS）