Development and validation of HPLC-UV method for the estimation of fulvestrant in bulk drug

Aim: The present work is aimed to develop a simple, rapid, selective, sensitive and validated HPLC method for the determination of fulvestrant in bulk drug. Method: Fulvestrant was measured using a validated HPLC method with UV detector at 225nm chromatographic peaks were separated on Phenomix, C18 column (250 mm x 4.6 mm x3.5?) using 50% aetonitrile in channel A and acetonitlile in channel B as mobile phase with gradient elution at a flow rate of 1 ml/min. Results & Discussions: The chromatograms showed good peak shapes and no interference of solvent peaks. The retention time of fulvestrant was found to be 13.6 min. LOD and LOQ were found to be 0.0226?g/ml (0.001%) and 0.0712?g/ml,(0.004%) respectively. The percentage recovery of fulvestrant was found to be 99.1% - 100.75% which are within the limit. The method was linear over the concentration range of 0.08to 2ìg/ml with coefficient of correlation (r2) 0.99997. Both intraday and inter day accuracy and precision data showed good reproducibility. Conclusions: The low % RSD values (= 2) indicated that the method was precise and accurate. this method was successfully applied to forced degradation studies and can be adopted for routine estimation of fulvestrant in quality control laboratories.