Abstract

DEVELOPMENT & VALIDATION OF STABILITY INDICATING RP-UPLC METHOD FOR QUANTITATIVE ESTIMATION OF ABACAVIR, LAMIVUDINE AND ZIDOVUDINE IN TABLET DOSAGE FORM

T. Benjamin and Dr. D. Ramachandran*

ABSTRACT

To develop an accurate, simple and reproducible RP-UPLC method for the simultaneous estimation of abacavir, lamivudine and zidovudine in bulk drug and in combined tablet dosage form. The separation was achieved by using column Purospher star RP18 Column (50mm X 2.1 mm, 2μ) in mobile phase consisted of pH 6.4 ammonium formate buffer used as mobile phase-A and mobile phase-B used as methanol and acetonitrile in the ratio of 50:50 v/v. Elution mode was gradient, flow rate was 0.3mL/min, column oven temperature 30° C, the injection volume was 1μL, and detection was performed at 272 nm using a photodiode array detector (PDA), Run time 7 minutes. The retention time of abacavir, lamivudine and zidovudine, was noted to be 1.07 minutes 2.8 minutes and 3.8 minutes respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

Keywords: Liquid Chromatography, abacavir, lamivudine and zidovudine, combined dosage forms; Simultaneous estimation, Validation.