Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF FOSAMPRENAVIR IN BULK FORM AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

Pragati Ranjan Satpathy*, Nilima Shukla, Bisakha Tripathy and Manas Ranjan Behera

ABSTRACT

A Novel, simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has been developed for the validated of Fosamprenavir in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Develosil ODS HG-5 RP C18, 5m, 15cm x 4.6mm i.d. with Methanol : Phosphate buffer (0.02M, pH-3.6) = 45:55% v/v as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 255nm; the constant column temperature was Ambient. The retention time of Fosamprenavir was found to be 3.254min. The calibration plot was linear over the concentration range of 12–28μg mL−1 with limits of detection and quantification values of 5.004 and 15.164μg mL−1 respectively. The mean % assay of marketed formulation was found to be 99.698%, and % recovery was found to be within the limits. The proposed method was simple, precise, specific, accurate and rapid, making it suitable for estimation of Fosamprenavir in bulk and marketed pharmaceutical dosage form dosage form.

Keywords: Fosamprenavir, RP-HPLC, ICH Guidelines, Accuracy, Precision.