Affiliation:
1. Quality Control Laboratory, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Brazil
Abstract
Background:
In intensive care units intravenous medicine may be used in simultaneous
infusion in the same intravenous site. Sometimes, the physical compatibility and stability of
the combined solutions are unknown.
Objective:
The objective was to develop, optimize and validate a simple, fast and sensitive stability-
indicating high-performance liquid chromatography (HPLC) for simultaneous quantification
of binary mixtures of norepinephrine, piperacillin + tazobactam, moxifloxacin for intravenous
(IV) administration in different diluents and physical compatibility with mannitol.
Methods:
The HPLC method was performed on a C18LUNA (4.6x250 mm 5-Micron) column,
using acetonitrile: methanol: phosphate buffer pH 3.0 (20:30:50) as eluent and validated according
to ICH guidelines and applied to mixtures of norepinephrine, moxifloxacin, piperacillin, tazobactam
and mannitol at 0, 2, 6, 9 and 24 h. The substances and their mixtures were also evaluated
by visual inspection and pH over time.
Results:
The analytical method developed was specific, linear, precise, accurate and robust. No
visual changes were observed in the mixtures over time, maintaining the pH values (except for
piperacillin + tazobactam which changed 0.5 in 24 h) and losses of less than 10% of content over
the 24 h under analyzed conditions.
Conclusion:
The proposed method is suitable for simultaneous analysis of norepinephrine, moxifloxacin,
piperacillin and tazobactam. All tested mixtures were compatible and stable for up to
24h, which is an important result for increasing patient safety in clinical practice since it has not
been reported in the literature yet. The method can be further investigated and used for different
concentration and diluent combinations.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics
Reference36 articles.
1. Moraes C.G.; Silva D.; Bueno D.; Analysis of intravenous drug incompatibilities in the adult intensive care unit of the Hospital de Clínicas de Porto Alegre. Revista HCPA 2011,31(1),31-38
2. Kanji S.; Lam J.; Johanson C.; Singh A.; Goddard R.; Fairbairn J.; Lloyd T.; Monsour D.; Kakal J.; Systematic review of physical and chemical compatibility of commonly used medications administered by continuous infusion in intensive care units. Crit Care Med 2010,38(9),1890-1898
3. Benlabed M.; Perez M.; Gaudy R.; Genay S.; Lannoy D.; Barthélémy C.; Odou P.; Lebuffe G.; Décaudin B.; Clinical implications of intravenous drug incompatibilities in critically ill patients. Anaesth Crit Care Pain Med 2019,38(2),173-180
4. López-Cabezas C.; Guerrero L.; Molas G.; Anglada H.; Soy D.; Physicochemical compatibility of high concentration drugs usually Y-site administered in intensive care units. Eur J Hosp Pharm Sci Pract 2015,22(2),107-112
5. Soares D.B.; Nascimento M.M.G.; Rosa M.B.; Pereira M.L.; Incompatibility between intravenous drugs in an adult intensive care unit of a large Brazilian hospital. J Appl Pharm Sci 2017,4(1),19-27