Development of Rp-HPLC method for fexofenadine determination in tablet formulations and development of dissolution method

ABSTRACT

Fexofenadine hydrochloride is a piperidine derivative. It is indicated to relive signs and symptoms that are related with seasonal allergic rhinitis, such as rhinorrhea, sneezing, nose, throat and itchy eyes. In the present research work a liquid chromatographic method was developed for the determination of Fexofenadine in tablets and the dissolution method by UV/VIS spectrophotometer was also developed. Method was developed by using Lichrospher 10 micro m [C18] column. The mobile phase is composed of acetonitrile-5mM ammonium acetate buffer [5050, v/v] pumped at a flow rate of 1 ml/min. The UV detector was operated at 254nm. The method was validated for system suitability, accuracy/recovery, linearity, system precision, method precision, ruggedness, robustness, limit of detection and limit of quantitation. Similarly, for dissolution method difference concentrations of standard and sample solutions were prepared i.e. 65 micro g/ml, 35 micro g/ml, 17.5 micro g/ml, 8.75 micro g/ml and 4.375 micro g/ml. The proposed HPLC method was easy, precise and fewer time consuming. The linearity for the dissolution method was found to be acceptable. The correlation coefficient of standard solutions was 0.9979 similarly the correlation coefficient of sample solutions was 0.9963