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Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation.
J Pharm Biomed Anal. 2007 Dec 21; 45(5):804-10.JP

Abstract

An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L(-1) for FEX (R(2)=0.9993) and between 325.6 and 610.5 mg L(-1) for PSE (R(2)=0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N=9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose.

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Authors+Show Affiliations

Maggio RM
Area Análisis de Medicamentos, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario S2002LRK, Argentina.
Castellano PM
No affiliation info available
Vignaduzzo SE
No affiliation info available
Kaufman TS
No affiliation info available

MeSH

CalibrationChromatography, High Pressure LiquidDrug CombinationsHistamine H1 Antagonists, Non-SedatingLeast-Squares AnalysisMolecular StructureNasal DecongestantsPseudoephedrineReproducibility of ResultsSpectrophotometry, UltravioletTabletsTerfenadineTime Factors

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17766076

Citation

Maggio, Rubén M., et al. "Alternative and Improved Method for the Simultaneous Determination of Fexofenadine and Pseudoephedrine in Their Combined Tablet Formulation." Journal of Pharmaceutical and Biomedical Analysis, vol. 45, no. 5, 2007, pp. 804-10.
Maggio RM, Castellano PM, Vignaduzzo SE, et al. Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation. J Pharm Biomed Anal. 2007;45(5):804-10.
Maggio, R. M., Castellano, P. M., Vignaduzzo, S. E., & Kaufman, T. S. (2007). Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation. Journal of Pharmaceutical and Biomedical Analysis, 45(5), 804-10.
Maggio RM, et al. Alternative and Improved Method for the Simultaneous Determination of Fexofenadine and Pseudoephedrine in Their Combined Tablet Formulation. J Pharm Biomed Anal. 2007 Dec 21;45(5):804-10. PubMed PMID: 17766076.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation. AU - Maggio,Rubén M, AU - Castellano,Patricia M, AU - Vignaduzzo,Silvana E, AU - Kaufman,Teodoro S, Y1 - 2007/07/27/ PY - 2007/05/28/received PY - 2007/07/17/revised PY - 2007/07/20/accepted PY - 2007/9/4/pubmed PY - 2008/2/1/medline PY - 2007/9/4/entrez SP - 804 EP - 10 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 45 IS - 5 N2 - An alternative method for the determination of fexofenadine (FEX) and pseudoephedrine (PSE) in their combined tablet formulation has been developed, employing the partial least squares (PLS) analysis of spectral data of the analytes in their pharmaceutical association. A full-factorially designed set of 16 synthetic samples was employed for calibration purposes. The calibration models were constructed with wavelengths selection, in the ultraviolet region, according to their predictive ability. These were validated internally by the leave-one-out procedure and externally, employing appropriate sets of validation samples. The described method was linear for both analytes, over the range 160.6-301.2 mg L(-1) for FEX (R(2)=0.9993) and between 325.6 and 610.5 mg L(-1) for PSE (R(2)=0.9992). It was accurate, exhibiting 99.8% and 99.9% drug recoveries for FEX and PSE, respectively (N=9), while in the intermediate precision experiment relative standard deviations were 1.4% for FEX and 1.2% for PSE. The contents of both analytes were assayed in commercial tablets employing this method and the results were compared with those furnished by HPLC, being in good statistical agreement. The method represents an improvement over the first derivative of spectral ratio (DSR) technique and allows high sample throughput with minimum reagent consumption and waste generation. The obtained results confirm that the method is highly suitable for its intended purpose. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/17766076/Alternative_and_improved_method_for_the_simultaneous_determination_of_fexofenadine_and_pseudoephedrine_in_their_combined_tablet_formulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(07)00438-4 DB - PRIME DP - Unbound Medicine ER -
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