Abstract
Two simple and sensitive Visible spectrophotometric methods (A and B) for the determination of Fexofenadine (FEX) in bulk sample and pharmaceutical formulations are described. Methods A and B are based on the formation of ion-association complex involving carboxylic acid group of FEX and the basic dyes, Safranin-O (SFN-O, method A), methylene blue (MB, method B). The results obtained in the above two methods are reproducible and are statistically validated and found to be suitable for the assay of Fexofenadine in bulk and its pharmaceutical formulations.
Highlights
Fexofenadine (FEX) is an antihistamine with selective peripheral H1-receptorantagonist activity and inhibited antigen induced bronco spasm
B.S.SASTRY et al, FEX being acidic in nature due to the presence of carboxylic acid group forms an ion-association complex with the basic dyes (SFN-O, method A or MB, method B), which is extractable into chloroform
The results show that a quantitative extraction was produced with a pH 9.0-10.0
Summary
Fexofenadine (FEX) is an antihistamine with selective peripheral H1-receptorantagonist activity and inhibited antigen induced bronco spasm. It is chemically known as (±)-4-[4-(hydroxyl-4-[4-(hydroxyl diphenyl- methyl) –1-piperdinyl]-butyl-α-α-dimethyl benzene acetic acid[1,2,3]. B.S.SASTRY et al., FEX being acidic in nature due to the presence of carboxylic acid group forms an ion-association complex with the basic dyes (SFN-O, method A or MB, method B), which is extractable into chloroform. Aqueous solutions of SFN-O (Fluka, 2.857x10-4M) and MB (Fluka, 3.12x10-4M) were prepared for methods A and B. The standard stock solution of FEX (1 mg/ml) was prepared by dissolving 100 mg of drug in 100 ml of chloroform. The working standard solutions were prepared by further dilution of the stock solution with chloroform (200 μg/ml for method A and method B)
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