ISSN: 2249–9504
CAS CODEN: IJPCDX

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE ESTIMATION OF VILDAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM

Abstract

Author(s): K. Hanumantha Rao1, A. Lakshmana Rao2* and KB. Chandra Sekhar3

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Vildagliptin in tablet dosage form. An Altima C18 column having 150 mm x 4.6 mm internal diameter, 5 µm particle size in isocratic mode with mobile phase containing dilute orthophosphoric acid solution pH 2.6±0.5 as buffer and acetonitrile (72:28 v/v) was used. The flow rate was 1.0 ml/min and effluents were monitored at 266 nm. The retention time for Vildagliptin was 3.25 min. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection and limit of quantification were found 0.06 µg/ml and 0.21 µg/ml respectively and recovery of Vildagliptin from tablet formulation was found 99.73%. The proposed method was successfully applied for the quantitative determination of Vildagliptin in tablet formulation.

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