Abstract:
OBJECTIVE To establish a method for detection of the residual solvents in idarubicin hydrochloride substance. METHODS The residual solvents in this substance were determined by GC equipped with FID detector and linked with DB-624 capillary column (30.0 m×0.530 mm, 3.00 mm ). The carries gas was nitrogen. The inlet temperature was 200 ℃ and the FID detector temperature was 250 ℃. The column temperature rose by program: the initial temperature was 50℃, maintained for 6 min, raise to 165 ℃ with a rate of 10 ℃·min
-1, maintained for 2.5 min. The flow rate of carries gas N2 was 4.0 mL·min
-1. The heated temperature of the headspace oven was 105 ℃, the heated time lasted 20 min, and the injection volume was 1.0 mL. The dissolved medium used to prepare all of the test solutions was DMF. RESULTS Each solvent could be completely separated in chromatogram obtained from systemic suitability test, and the calibration curves of each solvent had good linear relationship within a certain range . CONCLUSION The method is accurate and reliable. It can be applied in detection of residual solvents in buflomedil hydrochloride substance.