Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF AZILSARTAN MEDOXOMIL IN TABLET DOSAGE FORM

Reshma S. Kore*, Sonali P. Mahaparale and Ashlesha P. Bhagat

Abstract

Present study aims to develop a simple, precise and accurate method for estimation of Azilsartan Medoxomil in tablet dosage form. The wavelength and solvent system were optimized in order to maximize the sensitivity of the proposed method. Azilsartan shows the maximum absorbance at 248 nm. The separation was achieved on RP-HPLC Isocratic system equipped with HPLC Agilent 1100 series. The mobile phase was prepared with buffer pH 3.0 and ACN in the ratio of 55:45, pH was adjusted with o – phosphoric acid (pH 3.0). Run through Octadecylsilane Column 150mm X 4.6mm, 5μ (Hypersil BDS 18C) with a flow rate of 1.5 ml/min for 10 min run time. System suitability parameters like plate count and tailing factor were passed according to ICH guidelines. Percentage recovery of Azilsartan was 99.03%. Linearity was observed in the concentration range of 70-130% and correlation coefficient of Azilsartan was obtained 0.99962. Robustness was found to be within the limits i.e. not 2. Stability studies were done and % degraded was within limits. A simple method was developed for estimation of Azilsartan. The RP-HPLC method was developed and validated for estimation of Azilsartan Medoxomil in tablet dosage form.

Keywords: Azilsartan Medoxomil, RP-HPLC, Stability indicating, Method development, Validation.