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Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump

Author(s):  Tomasello Cristina, Leggieri Anna, Rabbia Franco, Veglio Franco, Baietto Lorena, Fulcheri Chiara, De Nicolò Amedeo, De Perri Giovanni, D'Avolio Antonio

Issue:  Jul/Aug 2016 - Volume 20, Number 4
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Abstract:  Urapidil is an antihypertensive agent, usually administered through intravenous bolus injection, slow-intravenous infusion, or continuous-drug infusion by perfusor. Since to date no evidences are available on drug stability in elastomeric pumps, patients have to be hospitalized. The purpose of this study was to validate an ultra-performance liquid chromatographic method to evaluate urapidil stability in an elastomeric infusion pump, in order to allow continuous infusion as home-care treatment. Analyses were conducted by diluting urapidil in an elastomeric pump. Two concentrations were evaluated: 1.6 mg/mL and 3.3 mg/mL. For the analyses, a reverse-phase ultra-performance liquid chromatographic– photodiode array detection instrument was used. Stressed degradation, pH changes, and visual clarity were used as stability indicators up to 10 days after urapidil solution preparation. The drug showed no more than 5% degradation during the test period at room temperature. No pH changes and no evidences of incompatibility were observed. Stress tests resulted in appreciable observation of degradation products. Considering the observed mean values, urapidil hydrochloride in sodium chloride 0.9% in elastomeric infusion pumps is stable for at least 10 days. These results indicate that this treatment could be administered at home for a prolonged duration (at least 7 days) with a satisfactory response.

Related Keywords: Cristina Tomasello, PharmD, Anna Leggieri, PharmD, Franco Rabbia, MD, ESH, Franco Veglio, MD, ESH, Lorena Baietto, PhD, Chiara Fulcheri, MD, Amedeo De Nicolò, BSc, MSc, Giovanni Di Perri, MD, DTM&H, PhD, Antonio D'Avolio, BSc, MSc, SM, urapidil, antihypertensive, severe refractory hypertension, high blood pressure, stability, elastomeric infusion pump, forced degradation, drug costs


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