Liquid chromatographic determination of cetirizine in oral formulations.
The development and validation of a reversed-phase liquid chromatographic (LC) method for the determination of cetirizine dihydrochloride in oral formulations are described. An isocratic LC analysis was performed on a reversed-phase C18 column (250 x 4.6 mm id, 5 microm particle size). The mobile phase was 1% orthophosphoric acid solution, pH 3.0-acetonitrile (60 + 40, v/v), pumped at a constant flow rate of 1.0 mL/min. Measurements were made at a wavelength of 232 nm. The calibration curves were linear over the range of 10-30 microg/mL (r2 = 0.9999). The relative standard deviation (RSD) values for intraday precision were 0.94 and 1.43% for tablets and compounded capsules, respectively. The RSD values for interday precision were 0.13 and 0.82% for tablets and compounded capsules, respectively. Recoveries ranged from 97.7 to 101.8% for tablets and from 98.4 to 102% for compounded capsules. No interferences from the excipients were observed. Because of its simplicity and accuracy, the method is suitable for routine quality-control analysis for cetirizine in tablets and compounded capsules.
Bajerski
Lisiane
L
Universidade Federal de Santa Maria, Departamento de Farmácia Industrial, Santa Maria, Brazil.
Cardoso
Simone G
SG
Diefenbach
Isabel Fraçao
IF
Malesuik
Marcelo Donadel
MD
Sílvia
Helena
H
Borgmann
Miollo
M
D002138:Calibration; D002214:Capsules; D017332:Cetirizine / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid; D006634:Histamine H1 Antagonists / Q000032:analysis*; D007202:Indicators and Reagents; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D002214:Capsules; D006634:Histamine H1 Antagonists; D007202:Indicators and Reagents; D013607:Tablets; D017332:Cetirizine