关键词: 丙亚胺；色谱法, 超高效液相；专用溶媒

Abstract: Objective  To investigate the stability of dexrazoxane for injection in dedicated or non-dedicated infusion solvents.
Methods  After dissolved in dedicated solvent(0.167 mol/L sodium lactate for injection) and non-dedicated solvent(sterile water for injection) respectively, dexrazoxane was placed at room temperature for 24 h, and the changes in appearance were observed. The value of pH was measured with pH meter. The number of insoluble particles was surveyed by particle analyzer. The relative percentage contents were measured by ultra-high performance liquid chromatography(UPLC), and the chromatographic conditions were as follows: chromatographic column was ACQUITY UPLC BEH C18(2.1 mm×50 mm,1.7 μm), the mobile phase was water-methanol(90〖DK〗∶10) with a flow rate of 0.4 mL/min, the detection wave length was set at 209 nm, and the column temperature was 25 ℃．
Results  Under this condition, the appearance and pH value had no significant change within 24 h. In comparison, the pH of a compatible fluid prepared with dedicated solvents was higher than that with sterile water for injection. The number of insoluble particles in the mixture dissolved by non-dedicated solvent and expanded to the compatibility solutions in 5% glucose injection exceeded the normal range, while the other compatibility solutions were within the normal range. The linear range of dexrazoxane was 4.30-42.96 mg/L(r=0.999 9). The relative percentage of dexrazoxane in the dedicated solvent group and non-dedicated solvent group were more than 95% and less than 95% within 6 h, repectively. The relative percentage of dexrazoxane was significantly decreased after 6 h in both groups.
Conclusion  The compatibility solution of dexrazoxane dissolved by dedicated solvent is more stable than that in non-dedicated solvent group.

Key words: razoxane, chromatography, ultra-high performance liquid, Dexrazoxane