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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/18739

Title: A validated reverse phase LC Method for the simultaneous estimation of Fexofanadine HCl and Pseudoephedrine HCl in pharmaceutical dosage form using a monolithic silica column
Authors: Z.Alzoman, Nora.
Hefnawy, Mohamed.
A. Sultan, Maha.
M. Maher, Hadir.
M. Alshehree, Mona.
V. Olah, Ileana.
Keywords: Fexofenadine hydrochloride; Pseudoephedrine hydrochloride; RP-LC; monolithic column; tablets
Issue Date: 2000
Publisher: Chemic Publishing Co.
Citation: Submitted to be published in Asian Journal of Chemistry.
Abstract: A simple, rapid, accurate, precise and sensitive isocratic reverse phase high performance liquid chromatographic method (RP-LC) has been developed for the simultaneous estimation of Fexofenadine HCl (FEX) and Pseudoephedrine HCl (PSE) in pharmaceutical dosage forms from their combination formulation. The proposed method utilized Chromolith ® Performance , RP-18e , 100 × 4.6mm column and the separation was achieved with mobile phase consisted of phosphate buffer pH 4.5 : acetonitrile : methanol (65: 25 : 10 v/v) , delivered at a flow rate of 2.4 ml/min and wavelength of detection at 258nm. Losartan was chosen as the internal standard which elution is between the two tested active ingredients to guarantee a high level of quantitative performance. The method has shown adequate separation using Losartan with good resolution to both of the active ingredients, in which contest the retention time of Pseudoephedrine HCl, Losartan and Fexofenadine HCl were 0.7, 2.1 and 2.7 min, respectively. The described method was linear over the range of 0.8- 100 µg mL-1 (r=0.9995) for Fexofenadine HCl and 2.0 – 200 µg mL-1 (r=0.9999) for Pseudoephedrine HCl . Intra- and inter-day % RSD (n=6) was ≤ 1.0%. The percentage recovery of the two drugs from their tablet formulation were 99.5 ± 0.3 (FEX) and 99.6 ± 0.4 (PSE). The developed method was validated according to ICH guidelines .The method can be used for rapid and accurate quantitative determination of these drugs in combined dosage forms.
URI: http://hdl.handle.net/123456789/18739
ISSN: 09707077
Appears in Collections:College of Pharmacy

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