Capillary electrophoresis method for fexofenadine hydrochloride in capsules.
A simple, accurate, and effective capillary electrophoresis method with ultraviolet absorbance detection was developed and validated for the quantitation of the antihistamine fexofenadine in capsules. The separation was performed with an uncoated fused-silica capillary (47 cm x 75 microm id) and was operated at 20 kV potential. Temperature was maintained at 25 degrees C. The run buffer was prepared with 20mM Na2B4O7 x 10 H2O. Software was used for system control, data acquisition, and analysis. Method validation was performed by evaluation of the analytical parameters linearity, precision, accuracy, limits of detection and quantitation, and specificity. The method was linear (r = 0.9999) at concentrations ranging from 20 to 100 microg/mL, precise (relative standard deviation intra-assay = 1.2, 1.6, and 1.8% and interassay = 1.5%); accurate (recovery = 98.1%); and specific. The limits of detection and quantitation were 0.69 and 2.09 microg/mL, respectively. The method was compared to the liquid chromatography method developed previously by the authors for the same drug, and no significant difference was found between the 2 methods in fexofenadine hydrochloride quantitation.
Breier
Ana R
AR
Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Av. Ipiranga, 2752, Lab. 402 Porto Alegre-RS, CEP 90610-000, Brazil. anarita_breier@hotmail.com
Garcia
Sílvia S
SS
Jablonski
André
A
Steppe
Martin
M
Schapoval
Elfrides E S
EE
D002021:Buffers; D002214:Capsules; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002853:Chromatography, Liquid / Q000379:methods; D004340:Drug Contamination; D019075:Electrophoresis, Capillary / Q000379:methods*; D006634:Histamine H1 Antagonists / Q000032:analysis*; D008956:Models, Chemical; D015203:Reproducibility of Results; D012822:Silicon Dioxide; D012984:Software; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods; D013696:Temperature; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000032:analysis; D014466:Ultraviolet Rays; D014867:Water / Q000032:analysis
D002021:Buffers; D002214:Capsules; D006634:Histamine H1 Antagonists; D014867:Water; D012822:Silicon Dioxide; D016593:Terfenadine; C093230:fexofenadine