Determination of Irbesartan Using Stability Indicating Reverse Phase Liquid Chromatographic and UV Spectrophotometric Method

Abstract

Objectives: The present research work involve the development of a novel UV-Spectrophotometric and stability-indicating RP-HPLC methods for the irbesartan in bulk as well as tablet dosage form. Methods: The RP-HPLC method is performed on the Phenomenex C18 column (150 x 4.6 mm, 5 μm) particle size, using 0.1% Formic acid buffer (pH 3.2): Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1.0 mL/min at the 220 nm detection wavelength. For the UV method the 0.1% formic acid was used as solvent. Validation study was performed for both the methods as per ICH guidelines. Results: A linear range of 1.5-120 μg/mL for HPLC and 1.75-110.5 μg/mL for UV method was obtained with a correlation coefficient of 0.998 for UV and 0.999 for HPLC method. The retention time of irbesartan was found 2.226 min using optimised condition. In force degradation study the acidic and alkaline conditions decomposes the irbesartan more in compared to other stressed conditions. In UV method the measurement of the absorbance of Irbesartan at λmax equals to 220 nm. The developed UV and HPLC methods was found suitable to assay the marketed tablet dosage form with the percentage purity values of 95.78% and 96.68%. All the other validation parameters were found within the limit that has been conducted as per the ICH guidelines. Conclusion: The developed methods were found novel, reliable and easy for the estimation of irbesartan in bulk and tablet dosage form.