Simple and reliable HPLC analysis of fexofenadine hydrochloride in tablets and its application to dissolution studies.
A simple RP-HPLC method using a PDA detector was developed and validated for the analysis and dissolution studies of fexofenadine hydrochloride (FEX) in dosage forms. Mobile phase: triethylamine phosphate 1%, pH 3.2: acetonitrile(ACN):methanol (50:30:20), 210 nm detection, C18 Phenomenex& column. The method was validated regarding accuracy/precision (RSD < 1%), linearity (r2 = 0.9999), and robustness. The method was applied to the determination of the drug in commercial tablet preparations and proved to be fast and reliable for quantification and it was also used for the comparison of dissolution profiles of FEX tablets. When we used the factor f2 as a comparison parameter, all the medium didn't present difference in the formulations, but just in the HCI 0.1 M the formulations showed similar results for the parameters f1/f2 andDE allowing to affirm that the two formulations are similar and with the same performance in vivo.
Oliveira
D C
DC
Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria, Santa Maria, RS, Brazil.
Weigch
A
A
Rolim
C M B
CM
D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D006634:Histamine H1 Antagonists / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000032:analysis
D006634:Histamine H1 Antagonists; D013607:Tablets; D016593:Terfenadine; C093230:fexofenadine