DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ABACAVIR, ZIDOVUDINE AND LAMIVUDINE IN TABLET DOSAGE FORMS

Abstract

The objective of the current study was to develop and validate a rapid, precise, specific reverse phase HPLC method for the stability indicating analysis of abacavir, zidovudine and lamivudine in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form. The dosage form was subjected to analytical studies as per International Conference on Harmonization (ICH) prescribed. It was found that abacavir, zidovudine and lamivudine is very sensitive to different conditions. The chromatographic conditions were optimized using the samples and regression analysis shows, ‘r’ value (correlation coefficient) 0.999, 0.999 and 0.999 respectively for all the three drugs. The chromatographic separation was achieved on a symmetry C18 (4.6 x 150mm, 3.5μm, Make: XTerra) or equivalent. The method employed an isocratic elution and the detection wave-length was set at 258 nm. The mobile phase consists of methanol:buffer (pH 3.5) delivered at a flow rate of 1.0 mL/min. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness and the degradations at different selected parameters.