ISSN: 2249–9504
CAS CODEN: IJPCDX

A NOVEL VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF ALBIGLUTIDE IN BULK

Abstract

Author(s): S. Susena* and K. Vanitha Prakash

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Albiglutide in bulk form. Isocratic elution at a flow rate of 1.0ml/min was employed on a symmetry C18 (250x4.6mm, 5μm in particle size) at ambient temperature. The mobile phase consisted of Methanol: phosphate Buffer (PH-5.5) 85:15(V/V). The UV detection wavelength was 246nm and 20μl sample was injected. The retention time for Albiglutide was 6.01 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 Albiglutide in bulk.

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