STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS OF ZIDOVUDINE AND LAMIVUDINE FROM THEIR COMBINATION DRUG PRODUCT

Abstract

A simple and precise chromatographic stability indicating reverse phased HPLC method for estimation zidovudine (ZDV) and lamivudine (LMV) from their combination product has been developed and validated using different validation parameters. In the developed RP HPLC method, YMC, Pack ODS A, (250 mm X 4.6 mm), 5 μm column is used. The mobile phase consisting of Acetate Buffer pH 4.0 and methanol in the proportion of 80:20 (v/v). The detection was done using photodiode array detector at 270 nm. The combination drug product of ZDV and LMV was exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analysed by the designed method. The data of peak homogeneity in stressed sample chromatograms of ZDV and LMV peaks, illustrated the specificity of the method for their estimation in presence of degradants. The described method was linear over a range of 0.025 ppm to 0.75 ppm for Zidovudine and 0.05 ppmto 1.50 ppm for lamivudine. The mean recoveries were 101.24and 97.63% for Zidovudine and Lamivudine, respectively.