Simultaneous Determination of Amlodipine and Irbesartan in their Pharmaceutical Formulations by Square-Wave...

Hypertension is one of the most important health problems in the world and irbesartan and amlodipine are used in combination in various dosages for the treatment of high blood pressure.

The aim of this study is to develop a fast, easy, sensitive, accurate, and precise squarewave voltammetry method for simultaneous determination of irbesartan and amlodipine besylate from pharmaceutical formulations at a hanging mercury drop electrode.

In the applied method, since both active substances gave a peak at different potentials, no interference occurred between them. In optimization studies, Britton-Robinson buffer of pH 8.0 was chosen, in which the most appropriate peak shape and maximum peak current were observed. At the same time, as a result of instrumental parameter optimization to obtain reproducible results, 6 mV for scan increment, 30 mV for pulse amplitude, and 50 Hz for frequency were found suitable.

As a result of the calibration studies of the optimized method, linear working ranges were determined as 1.00-13.08 μg mL-1 for irbesartan and 5.83-16.51 μg mL-1 for amlodipine besylate. Limit of detection and limit of quantitation values were respectively calculated as 0.63 and 1.00 μg mL-1 for irbesartan and 0.50 and 1.98 μg mL-1 for amlodipine besylate. The results of precision values (RSD) ranged from 0.67% to 2.31% for irbesartan and 0.65% to 1.49% for amlodipine besylate. Accuracy values were calculated as -0.15% to 1.63% for irbesartan and -0.07% to 3.78% for amlodipine besylate. The results obtained from the recovery studies ranged from 101.05% to 102.78% and from 98.88% to 102.20% for amlodipine besylate and irbesartan, respectively.

After the validation studies of the developed method were carried out, it was successfully applied to pharmaceutical formulations containing these active substances.