Abstract

A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Sitagliptin tablet dosage form. Isocratic elution at a flow rate of 1ml/min was employed on a Kromasil C18 (250×4.6mm, 5µm in particle size) at ambient temperature. The mobile phase consisted Methanol: Acetonitrile: Water 70:10:20 v/v/v. The UV detection wavelength was 285nm and 20µl sample was injected. The retention time for Sitagliptin was 4.583min. The % RSD for precision of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Sitagliptin tablet dosage form and bulk drug.

Issue

The Experiment 2012

Article Subject:

Biotechnology

KeyWords:

Sitagliptin, RP-HPLC, UV detection, recovery, precise, 285nm

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Nallagatla. Vijaya Bhaskar Rao et al , The Experiment, December. 2012 , Vol. .5(5). 315-323