Stability Indicating Analytical Method Development and Validation of Fexofenadine by RP-HPLC Method.

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Mahesh Hari Kolhe, Saurabh Changdev Jejurkar, Rohit Jaysing Bhor, Sameer Narayan Godase


Introduction: Fexofenadine in pharmaceutical dosage form can use to treat and control s used for the treatment of allergic rhinitis and chronic urticaria through the antagonism of histamine receptors H1.
Objective: The objective is to develop a novel, easy, fast, accurate RP-HPLC method and validate it as per the ICH guidelines. This method aims to determine both Fexofenadine in pure and pharmaceutical formulation. 
Method: Separation of analyte was carried out using an Agilent C18 (5μm; 4.6 x 250 mm ID) column connected to a DAD detector. The moving phase consists of methanol and Formic acid in (40:60) with flow rate 0.8 ml per minute. Analytes were detected at 240 nm wavelength.
Result: Under optimized condition the retention time was found to be 4.523for Fexofenadinewith sharp peak. The linearity of a method was found at 24-120µg/ml for Fexofenadinehaving a coefficient of correlation (R2) 0.999.  Fexofenadine Limit of Quantification and Limit of Detection were determined to be 0.7185 and 0.2371. The procedure is accurate, as demonstrated by the founded good percent recovery. 
Conclusion: The method was developed and validated as per guidelines of International Conference on Harmonization. Forced degradation study ofthe drug was done in controlled acidic, basic, peroxide and hydrolysis condition. The develop method shows its suitability for the regular quantitative analysis Fexofenadine in their pure form and in its pharmaceutical formulation. This application of method serves for the purpose of quality control.

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