Abstract
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF RITONAVIR AND FOSAMPRENAVIR IN DRUG PRODUCT

*T. N. V. S. S. Satyadev

ABSTRACT

The aim of the method was to develop and validate a rapid, sensitive and accurate method for simultaneous estimation of Fosamprenavir and Ritonavir in drug product by liquid chromatography. The chromatographic separation was achieved on Phenyl column (Zorbax SB C18 250*4.6, 5um) at ambient temperature.The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoroacetic acid in water: Methanol (25:75). The flow rate was 0.8ml/ minute and ultraviolet detector at 240nm. The average retention time for Fosamprenavir and Ritonavir found to be 2.689 min and 4.096 min. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 140.0 -420.0μg/mL for Fosamprenavir and 20.0 -60.0μg/mL of Ritonavir.

Keywords: Fosamprenavir, Ritonavir, Isocratic, HPLC, Phenyl, Trifluoroacetic acid, Acetonitrile, Methanol, and validation.


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