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ISSN 2063-5346
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ANALYTICAL QUALITY BY DESIGN METHODOLOGY FOR BEXAGLIFLOZIN ASSESSMENT IN FORMULATION IN THE PRESENCE OF DEGRADANTS USING RP-HPLC

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K. Swaroopa Rani, B. Ramya Kuber
» doi: 10.53555/ecb/2023.12.7.362

Abstract

In patients with type 2 diabetes mellitus, bexagliflozin (BXN) inhibits sodium-glucose co-transporter 2, which is used to induce glycemic control. Evaluation of its quality is the necessary factor of these days. The current work is based on the analytical quality by design (AQbD) approach, which is now required by law. Central Composite design was selected for obtaining experimental combinations in Design Expert software. The dependent critical quality attributes (CQA), which are theoretical plates, retention time, and tailing factor, were only responding to the three critical process parameters, namely flow rate, aqueous mobile phase ratio, and temperature. Analysis of variance was used to examine the responses. The ideal method conditions included an Agilent column 150×4.6 mm, 5μm, with a mobile phase of a mixture containing buffer-0.1% ortho phosphoric acid and acetonitrile (60:40 v/v) pumped at a flow rate of 0.8 ml/min. The ICH guidelines served as the foundation for the method validation. The concentration range for the linear method is 0.5-30 μg/ml. The limits for quantitation and detection were set at 0.14 μg/ml and 0.05 μg/ml, respectively. With a run time of six minutes, the BXN was held at 2.2 minutes, displaying the maximum absorbance wavelength at 220.0 nm. The information from the contour graphs of responses was harmonized with the experimental results. So this method was apt for quantifying the dosage form and also the method was used for estimating the drug in the presence of degradants.

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