DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF IRBESARTAN BY THE HYDROTROPHY TECHNIQUE

Abstract

Irbesartan is a class II crystalline drug according to the Biopharmaceutical Classification System, the solubility of which in water is less than 0.1 mg/mL, and thus it possess a challenge for developing methods of its analysis. Hydrotrophy is one such phenomenon in which water-soluble agents enhance the solubility of hydrophobic compounds, precluding the use of toxic organic solvents. Among various hydrotropes screened, 1 M sodium acetate showed solubility enhancement of irbesartan by 33 times. After checking the effect of molarity from 0.5 to 4 M, 1 M sodium acetate showed characteristic absorption peaks and obeyed the Beer-Lambert law for 10-20 μg/mL solution of irbesartan hydrotrope mixture. Based on the plot of the concentration v/s absorbance, the calibration curve equation was found to be y = 0.040x - 0.013 with a correlation coefficient of 0.998. The LOD and LOQ values were found to be 0.3 and 1. The proposed method was validated for accuracy and precision at three suitable levels of concentration, i.e., 10, 14, and 18 μg/mL, for which the RSD was found to be 0.09, 0.07, and 0.1%, respectively. It was found that the method is robust and specific in the presence of other excipients and shows RSD values of 0.4, 0.5, and 0.6%, which are within acceptable limits.