A NOVEL RP ? HPLC METHOD FOR THE QUANTIFICATION OF LINAGLIPTIN IN FORMULATIONS

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.