SIMPLE COST-EFFECTIVE METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF REMOGLIFLOZIN ETABONATE AND VILDAGLIPTIN IN COMBINED DOSAGE FORM

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Authors: Manish Kumar Kesharwani, B.K Dubey, Vivek Singh Thakur, Deepak Kumar Basedia, Prabhat Kumar Jain, Sunil Shah
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Abstract

A simple, rapid, and cost-effective high-performance liquid chromatography (HPLC) method was developed and validated for the simultaneous estimation of Remogliflozin Etabonate (RGE) and Vildagliptin (VGT) in combined tablet dosage form. Chromatographic separation was achieved using a C18 column (250 × 4.6 mm, 5 μm) with a mobile phase of 20 mM KH₂PO₄:acetonitrile (20:80, v/v) at a flow rate of 1.0 mL/min and detection at 254 nm. The method demonstrated good linearity over the concentration ranges of 2–10 μg/mL for RGE and 1–5 μg/mL for VGT, with correlation coefficients (r²) of 0.999. Accuracy was confirmed through recovery studies (96.92–99.26% for RGE and 98.48–99.03% for VGT), while precision was verified by intra-day, inter-day, and analyst-to-analyst studies (%RSD

Fields of Study & Subjects

Analytical Methods in Pharmaceuticals Biosimilars and Bioanalytical Methods Analytical Chemistry and Chromatography

Publication details

Journal / source
Zenodo (CERN European Organization for Nuclear Research)
Publication date
12 February 2026
Language
EN