Validated RP – HPLC Method for the Estimation of Denosumab in Formulation
Abstract
A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Denosumab in tablet dosage form. Isocratic elution at a flow rate of 1.0ml/min was employed on a symmetry C18 (250×4.6mm, 5μm in particle size) at ambient temperature. The mobile phase consisted of methanol: water: O.P.A 90:10:01 (V/V/V). The UV detection wavelength was 233 nm and 20μl sample was injected. The retention time for Denosumab was 3.64 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 Denosumab in tablet dosage form.
Issue
IJAPSBS vol 1 (2012)
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Keywords:
Denosumab, RP-HPLC, UV detection, recovery, precise, 233 nm
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