Abstract

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR ASSAY OF LINAGLIPTIN IN BULK AND MARKETED DOSAGE FORM

Manpreet Kaur Sandhu*, Rajeshwar K. K. Arya and Dr. P. L. Sahu

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 Nucleodur C18 (150x4.6mm, 5μm in particle size) at 50ºC temperature. The mobile phase consisted of Buffer: Acetonitrile: Methanol (68:85:15 (v/v/v). The UV detection wavelength was 225 nm and 5μl sample was injected. The retention time for Linagliptin was 3.61 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.

Keywords: Linagliptin, RP-HPLC, UV detection, recovery, precise, 225 nm.