Abstract
A NOVEL STABILITY INDICATING VALIDATED RP-HPLC METHOD FORSIMULTANEOUS DETERMINATION OF AZILSARTAN AND AMLODIPINE BESYLATE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

G.Kumara Swamy*, JM Rajendra Kumar and J.V.L.N.Seshagiri Rao

ABSTRACT

A simple, precise, accurate and economical stability-indicating RP-HPLC assay method was developed and validated for simultaneous estimation of Azilsartan (AZN) and Amlodipine Besylate (AMD) in bulk drugs and their combined commercial tablets. The method has shown adequate separation of AZN and AMD from their degradation products. Separation was achieved on a Symmetry C18 (4.6 x 250mm, 5m, Make: Waters) or equivalent) column using a mobile phase consisting of a mixture of Acetonitrile: Potassium Dihydrogen Phosphate buffer Adjust pH 3.0 with ortho phosphoric acid (70:30, v/v).a isocratic elution mode at a flow rate of 1 ml/min. The retention times for AZN and AMD were found to be 3.5 and 2.3 min respectively. Both drugs and their combination drug product were subjected to acid, base, hydrolysis, thermal and photolytic stress conditions. Thus stressed samples were analyzed by the proposed analytical method. Validation of the proposed analytical method was carried out as per ICH guidelines Q2R1. Quantitation was achieved with PDA detection at 254 nm based on peak area with linear calibration curves at concentration ranges 2.5-20μg/ml for AZN and 10-80μg/ml for AMD (R2 > 0.9999 for both drugs). The LOD and LOQ were 3.09μg/ml, 2.90μg/ml and 10.1μg/ml, 9.84μg/ml for Azilsartan and Amlodipine Besylate respectively. The method was found to be specific and stability indicating as no interfering peaks of degradents and excipients were observed. The proposed method is suitable for application in quality-control laboratories for quantitative analysis of both the drugs individually and in combination dosage forms.

Keywords: RP-HPLC Method Azilsartan and Amlodipine Besylate and PDA Detector; Forced degradation studies; Tablet dosage forms


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