Journal: Journal of Pharmacy Research

Article Id: JPRS-PA-00001131
Title: Development and validation of HPLC-UV method for the estimation of fulvestrant in bulk drug
Category: Pharmaceutical Analysis
Section: Editorial
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    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 x3.5µ) 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 0.0226µg/ml (0.001%) and 0.0712µg/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.

    Cite this article as:Rama Mohan Reddy Thummaluru, Srikanth Gurrala,Development and validation of HPLC-UV method for the estimation of fulvestrant in bulk drug,Journal of Pharmacy Research 2016,10(1),21-24.

     

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    Author(s) Name:

    T. RAMA MOHANA REDDY, SRIKANTH GURRALA

    Affiliation(s) Name:

    DEPARTMENT OF PHARMACEUTICAL CHEMISTRY,

    CMR COLLEGE OF PHARAMACY, KANDLAKOYA, HEDERABAD, TELANGANA.

    rammohanreddy40@gmail.com, steev.g99@gmail.com

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    Author:

    T. RAMA MOHANA REDDY, SRIKANTH GURRALA

    Title:Development and validation of HPLC-UV method for the estimation of fulvestrant in bulk drug
    Journal:Journal of Pharmacy Research
    Vol(issue):10 (January)
    Year:2016
    Page No: (21-24)
  • Experimental Methods Keywords

    Methodology: HPLC method with UV detector at 225nm, 50% aetonitrile in channel A and acetonitlile in channel B as mobile phase with gradient elution
    Research Materials:

Keywords

FULVESTRANT HPLC-UV METHOD VALIDATION ICH GUIDELINES

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