Determination and Validation of RP-HPLC Method for the Estimation of Fosamprenavir in Tablet Dosage Form

Authors: Karnakar N , Srinivasa RA , Kishore AVB , Ramana H , Amani P and Ramesh

DOI: 10.23880/oajpr-16000292

Volume 7, Issue 4

Abstract

A new simple, accurate, profitable, rapid-fire and precise rear phase high performance liquid chromatographic system has been developed for the validated of Fosamprenavir in bulk form and its pharmaceutical lozenge form. Chromatographic separation was carried out on Zorbax C18(4.6mm X 250mm, 5m, Make X terra) column using a admixture of Acetonitrile Methanol Water (503020 v/v) as the mobile phase at an inflow rate of 1.0ml/min , the discovery was carried out at 265nm. The retention time of the Fosamprenavir was set up to be 5.462±0.02 min. The system was validated according to ICH guidelines for linearity, perceptivity, delicacy, perfection, particularity and robustness. The response was set up to be direct in the medicine attention range of 50−90_mcg/ml for Fosamprenavir. The correlation measure was set up to be 0.999. The LOD and LOQ for Fosamprenavir were set up to be 1.6_µg/ml and 4.8_µg/ml independently. The proposed system was set up to be good chance recovery for Fosamprenavir, which indicates that the proposed system is largely accurate. The system perfection for the determination of assay was below 2.0 RSD. The system is useful in the quality control of bulk and retailed pharmaceutical phrasings

Keywords: Fosamprenavir; RP-HPLC; Method Development; Validation; ICH Guidelines

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