STABILITY OF NICARDIPINE HYDROCHLORIDE IN INTRAVENOUS SOLUTIONS

The stability of nicardipine hydrochloride in large-volume i.v. soluti ons was studied. Admixtures of nicardipine hydrochloride 0.05 and 0.5 mg/mL were prepared in 5% dextrose and 0.45% sodium chloride injection , 5% dextrose and 0.9% sodium chloride injection, 0.45% sodium chlorid e injection, 0.9% sodium chloride injection, 5% dextrose and lactated Ringer's injection, 5% dextrose injection, lactated Ringer's injection , 5% sodium bicarbonate injection, and 5% dextrose injection with pota ssium chloride 40 meq/L. Two glass and two polyvinyl chloride (PVC) co ntainers of each solution were prepared and stored at ambient room tem perature under normal fluorescent light. Samples were removed and test ed for nicardipine concentration by stability-indicating highperforman ce liquid chromatography at 0, 24, 48, and 72 hours and seven days. Te sting included visual checking and optical density measurements. The a dmixtures remained clear and slightly yellow,except for nicardipine hy drochloride in sodium bicarbonate injection; which showed immediate pr ecipitation, and nicardipine hydrochloride in lactated Ringer's inject ion, which increased in optical density at 400 nm over time. There wer e no significant changes in nicardipine concentrations in glass contai ners. Admixtures stored in PVC containers showed a slow, constant decl ine in nicardipine concentrations, sometimes to less than 85% of the i nitial drug concentration within 24 hours, except for nicardipine hydr ochloride in lactated Ringer's injection or 5% dextrose and lactated R inger's injection, which showed an immediate and continuing rapid loss . Nicardipine hydrochloride 0.5 and 0.05 mg/mL in eight i.v. solutions was stable in glass containers for up to seven days. Drug concentrati ons slowly decreased in PVC containers. The drug was not stable in 5% sodium bicarbonate injection or in PVC bags containing lactated Ringer 's injection or 5% dextrose and lactated Ringer's injection.