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ISSN 2063-5346
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RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF METFORMIN, VILDAGLIPTIN AND REMOGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

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Kedar A. Jagtap, Vasudha S. Bavadekar, Pravin D. Chaudhari , Geeta A. Anawade , Akshata B. Birajdar
» doi: 10.31838/ecb/2023.12.s3.735

Abstract

A precise and robust method was developed for estimation of Metformin (MET), Vildagliptin (VDG) and Remogliflozin (RMG) in bulk and formulations by RP-HPLC technique. The Method used Agilent 1260 Infinity II model HPLC with DAD detector and Agilent Zorbax SB-Aq Column with dimension 250 x 4.6 mm, 5 m. The Mobile phase combination used was Phosphate Buffer pH 3.3 and Acetonitrile (50:50). Flow rate at 1.0 ml/min and wavelength at 210 nm with run time of 15 minutes. The retention time of MET, VDG and RMG peaks was at 2.21, 3.68 and 8.14 minutes, respectively. The method was validated as per ICH guidelines. The instrument precision for MET, VDG & RMG had a %RSD of 0.75%, 0.72 and 1.04%, respectively. Method was linear and accurate for concentration range 400-600 g/ml for MET, 40-60g/ml for VDG and 80-120g/ml for RMG with regression coefficient for MET, VDG & RMG of 0.9999, 0.9994 and 0.9996, respectively and % RSD for accuracy for MET at 80%, 100% and 120% was found to be 0.57%, 0.44% and 0.31%, respectively; for VDG at 80%, 100% and 120% was found to be 0.06%, 0.33% and 0.18% respectively; and for RMG at 80%, 100% and 120% was found to be 0.29%, 0.89% and 0.29% respectively.

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