Abstract

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

Page(s): 343-346

Download in electronic PDF format for $75
  • Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump Page 1
  • Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump Page 2
  • Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump Page 3
  • Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump Page 4

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

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy
Title/Author
(Click for Abstract / Details / Purchase)
Jul/Aug 2016
Pg. 343-346
Jul/Aug 2021
Pg. 330-335
May/Jun 2011
Pg. 252-254
Sep/Oct 2015
Pg. 432-436
Jul/Aug 2000
Pg. 281-285
Author(s): Ashworth Lisa D
Mar/Apr 2004
Pg. 153-155
Author(s): Gupta Vishnu D
Sep/Oct 2010
Pg. 436-439
May/Jun 2004
Pg. 228-230
Sep/Oct 2017
Pg. 436-439
Mar/Apr 2011
Pg. 94-100
Author(s): Miron Karen E
Jul/Aug 2015
Pg. 344-347
May/Jun 2002
Pg. 226-229
Nov/Dec 1998
Pg. 466-468
Jul/Aug 2000
Pg. 280
Author(s): Molitor Richard
Mar/Apr 2017
Pg. 150-153
Jul/Aug 2017
Pg. 322-329
Jul/Aug 2001
Pg. 323-324
Author(s): Quay Irene, Tan Edward
May/Jun 2005
Pg. 201-205
Mar/Apr 2002
Pg. 152-154
Jan/Feb 2002
Pg. 66-69