Volume : 13, Issue : 02, February – 2026

Title:

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

Authors :

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

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 <1.2%). The method was robust, sensitive (LOD 0.10 μg/mL for RGE and 0.15 μg/mL for VGT), and suitable for routine quality control analysis. The validated method was successfully applied to marketed tablet formulations, providing reliable quantification of both drugs.
Keywords: Remogliflozin Etabonate, Vildagliptin, HPLC, Simultaneous Estimation, Method Validation, Linearity, Accuracy, Precision, Robustness, Tablet Formulation

Cite This Article:

Please cite this article in press Manish Kumar Kesharwani et al., Simple Cost-Effective Method Development And Validation For The Estimation Of Remogliflozin Etabonate And Vildagliptin In Combined Dosage Form, Indo Am. J. P. Sci, 2026; 13(02).

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