Spectrophotometric Estimation of Azelnidipine in Bulk drug and Pharmaceutical Dosage form by First Order Derivative and Area Under Curve Methods

Simple and precise UV- spectrophotometric methods, first order derivative and area under curve [AUC], have been developed and validated for the estimation of azelnidipine in bulk drug and its tablet formulation. The standard and sample solutions of azelnidipine were prepared in methanol. Azelnidipine was estimated at 242.6 nm for the first order derivative UV-spectrophotometric method (A) while in area under curve (AUC) method (B) the zero order spectrum of azelnidipine was measured in between 250.5 nm to 258.8 nm. Beer’s law was obeyed in the concentration range of 1 to 20 μg / ml with coefficient of correlation value 0.9993 for first order derivative method. Similarly in AUC method, Beer’s law was obeyed in the concentration range of 1 to 20 μg / ml with coefficient of correlation value 0.9991. These methods were tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation, which was within the range of 0.1157 to 0.9995 % for the above two methods. The proposed methods were successfully applied for the determination of azelnidipine 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.