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Simple and reliable HPLC analysis of fexofenadine hydrochloride in tablets and its application to dissolution studies.
Pharmazie. 2007 Feb; 62(2):96-100.P

Abstract

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.

Authors+Show Affiliations

Oliveira DC
Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria, Santa Maria, RS, Brazil.
Weigch A
No affiliation info available
Rolim CM
No affiliation info available

MeSH

CalibrationChemistry, PharmaceuticalChromatography, High Pressure LiquidHistamine H1 AntagonistsReference StandardsReproducibility of ResultsSolubilitySpectrophotometry, UltravioletTabletsTerfenadine

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17341026

Citation

Oliveira, D C., et al. "Simple and Reliable HPLC Analysis of Fexofenadine Hydrochloride in Tablets and Its Application to Dissolution Studies." Die Pharmazie, vol. 62, no. 2, 2007, pp. 96-100.
Oliveira DC, Weigch A, Rolim CM. Simple and reliable HPLC analysis of fexofenadine hydrochloride in tablets and its application to dissolution studies. Pharmazie. 2007;62(2):96-100.
Oliveira, D. C., Weigch, A., & Rolim, C. M. (2007). Simple and reliable HPLC analysis of fexofenadine hydrochloride in tablets and its application to dissolution studies. Die Pharmazie, 62(2), 96-100.
Oliveira DC, Weigch A, Rolim CM. Simple and Reliable HPLC Analysis of Fexofenadine Hydrochloride in Tablets and Its Application to Dissolution Studies. Pharmazie. 2007;62(2):96-100. PubMed PMID: 17341026.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simple and reliable HPLC analysis of fexofenadine hydrochloride in tablets and its application to dissolution studies. AU - Oliveira,D C, AU - Weigch,A, AU - Rolim,C M B, PY - 2007/3/8/pubmed PY - 2007/4/4/medline PY - 2007/3/8/entrez SP - 96 EP - 100 JF - Die Pharmazie JO - Pharmazie VL - 62 IS - 2 N2 - 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. SN - 0031-7144 UR - https://www.unboundmedicine.com/medline/citation/17341026/Simple_and_reliable_HPLC_analysis_of_fexofenadine_hydrochloride_in_tablets_and_its_application_to_dissolution_studies_ L2 - https://antibodies.cancer.gov/detail/CPTC-RRM2-2 DB - PRIME DP - Unbound Medicine ER -