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Abstract

A VALIDATED RP-HPLC METHOD FOR ESTIMATION OF VILDAGLIPTIN IN BULK AND TABLET DOSAGE FORMS

Kumaraswamy Gandla*, G. Sravan, M. Ravinder and M. Bindu

ABSTRACT

The proposed research method accurate and precise RP-HPLC method has been developed for the validation of Vildagliptin, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex C18 (4.6×250mm, 5μ) column using a mixture of Water: Methanol (70: 30 v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 265 nm. The retention time of the Vildagliptin was 3.5 min. The method produce linear responses in the concentration range of 10-50μg/ml of Vildagliptin. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Vildagliptin, Tablet dosage forms; RP-HPLC, ICH validation.


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