Article Subject
Biotechnology
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 (250x4.6mm, 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.

Keywords
Sitagliptin
RP-HPLC
UV detection
recovery
precise
285nm.
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