A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF ABACAVIR IN BULK AND TABLET DOSAGE FORMS

Abstract

A rapid, precise, accurate, specific and simple RP-HPLC method was developed for the estimation of Abacavir in bulk and in tablet dosage form. A High performance liquid chromatograph 10AT SHIMADZU- SPD10A, using Phenomenex - Luna RP-18(2),250X4.6mm, 5 mm column, with a mobile phase composed  from water: Acetonitrile [80:20 %(v/v)] were used. The flow rate of 1.0 ml/min and the effluent was detected at 285 nm by using a UV detector. The retention time of Abacavir was 7.761 min. Linearity was observed over concentration range of 100-2800 ng ml^-1. The Limit of detection was found to be 21.04 ng ml^-1while quantification limit was 63.77 ng ml^-1. The accuracy of the proposed method was determined by recovery studies and found to be 98.23 to 100.61 %. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to stability studies and routine analysis of Abacavir in bulk and pharmaceutical formulations.

The proposed method was validated for various ICH parameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity.