A NOVEL RP – HPLC METHOD FOR THE QUANTIFICATION OF LINAGLIPTIN IN FORMULATIONS
Journal Title: Journal of Atoms and Molecules - Year 2012, Vol 2, Issue 2
Abstract
A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Linagliptin in tablet dosage form. Isocratic elution at a flow rate of 1.0 ml/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5μm in particle size) at ambient temperature. The mobile phase consisted of Acetonitrile: Water: Methanol (25:50:25 (v/v/v). The UV detection wavelength was 238 nm and 20μl sample was injected. The retention time for Linagliptin was 7 min. The percentage RSD for precision and accuracy 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 Linagliptin in tablet dosage form and bulk drug.
Authors and Affiliations
Lakshmi B, TV Reddy
Keywords
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- EP ID EP367477
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