Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump.
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.
Hospital Pharmacy, Maria Vittoria Hospital. cristina.tomasello@aslto2.piemonte.it.|Unit of Infectious Diseases, Laboratory of Clinical Pharmacology and Pharmacogenetic, Amedeo di Savoia Hospital, Turin, Italy.
Cristina
C
Tomasello
San Giovanni Bosco and Maria Vittoria Hospitals, Turin, Italy.
Anna
A
Leggieri
Internal Medicine and Hypertension Division, Department of Medical Sciences, University of Turin, Città della Salute e della Scienza Hospital, Turin, Italy.
Franco
F
Rabbia
Internal Medicine and Hypertension Division, Department of Medical Sciences, University of Turin, Città della Salute e della Scienza Hospital, Turin, Italy.
Franco
F
Veglio
Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Amedeo di Savoia Hospital, Turin, Italy.
Lorena
L
Baietto
Internal Medicine and Hypertension Division, Department of Medical Sciences, University of Turin, Città della Salute e della Scienza Hospital, Turin, Italy.
Chiara
C
Fulcheri
Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Amedeo di Savoia Hospital, Turin, Italy.
Amedeo
A
De Nicolò
Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Amedeo di Savoia Hospital, Turin, Italy.
Giovanni
G
De Perri
Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Amedeo di Savoia Hospital, Turin, Italy.
Antonio
A
D'Avolio
D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000737:chemistry*; D056148:Chromatography, Reverse-Phase; D004339:Drug Compounding; D004355:Drug Stability; D020724:Elastomers; D004867:Equipment Design; D006863:Hydrogen-Ion Concentration; D007260:Infusion Pumps; D007262:Infusions, Intravenous; D007552:Isotonic Solutions; D010879:Piperazines / Q000008:administration & dosage / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry*; D012965:Sodium Chloride / Q000737:chemistry*; D013696:Temperature; D013997:Time Factors
D000959:Antihypertensive Agents; D020724:Elastomers; D007552:Isotonic Solutions; D010879:Piperazines; D011108:Polymers; C036925:elastomeric polymer; D012965:Sodium Chloride; C015568:urapidil