Analysis of Compatibility Stability of Dobutamine Hydrochloride Injection

ZHOU Fangbing; LI Yang; GENG Shuang; PENG Yuhui

Abstract：Objective To investigate the stability of dobutamine hydrochloride injection,0.9％sodium chloride injection or 10％glucose injection after mixing with two different materials(PVC/TPE)infusion sets,so as to provide reasonable basis for clinical scientific drug use.Methods To simulate the clinical application method,0.9％sodium chloride iniection or 10％glucose was used as the compatible solvent,which was diluted into a solution containing dobutamine with a concentration of 0.25～5.0 mg/mL,and a HPLC method for the determination of related substances in dobutamine hydrochloride injection was established and verified.The compatibility stability of two different materials of dobutamine hydrochloride injection was investigated,and the key quality attributes were also studied.Results Dobutamine hydrochloride injection was stable within 35 hours after being mixed with different compatible solvents and infusion sets made of different materials,and it could be used for clinical application,and the results of compatibility stability met the quality standards of this product.Conclusion The HPLC method developed in this paper is suitable for testing the compatibility stability,and the compatibility of this product with 0.9％sodium chloride solution is more stable,and the safety of infusion set made of TPE is better than that of PVC.