UV Spectrophotometric Estimation of Fexofenadine hydrochloride by First Order Derivative and Area under Curve Methods in Bulk and Pharmaceutical Dosage Form

[摘要] Simple and precise UV spectrophotometric methods by first order derivative and area under curve [AUC] - have been developed and validated for the estimation of fexofenadine hydrochloride in bulk and its tablet formulation. The standard and sample solutions of fexofenadine hydrochloride were prepared in 0.1 N Hydrochloric acid. Fexofenadine hydrochloride was estimated at 225 nm for the first order derivative UV-spectrophotometric method (A), while in area under curve (AUC) method (B) the zero order spectrum of fexofenadine hydrochloride was measured in between 215 nm to 225 nm. Beer’s law was obeyed in the concentration range of 1 to 14 μg / ml with coefficient of correlation value 0.9998 for first order derivative method. Similarly in AUC method, Beer’s law was obeyed in the concentration range of 1 to 14 μg / ml with coefficient of correlation value 0.9941. These methods were tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation were of 0.5873 % and 0.1394 % for the above two methods respectively. The proposed methods were successfully applied for the determination of fexofenadine hydrochloride in pharmaceutical formulation. Results of the analysis were validated statistically and were found to be satisfactory. The proposed methods are simple, easy to apply, low-cost and require relatively inexpensive instruments.

[学科分类] 药理学