A Novel RP-HPLC Method for the Quantification of Fulvestrant in Formulations

A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Fulvestrant in tablet dosage form. Isocratic elution at a flow rate of 1 ml/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5µm in particle size) at ambient temperature. The mobile phase consisted of Methanol: 1% OPA: 85:15 % (V/V). The UV detection wavelength was 243 nm and 20µl sample was injected. The retention time for Fulvestrant was 5.3 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 Fulvestrant in tablet dosage form and bulk drug.