SIMULTANEOUS STABILITY-INDICATING METHOD FOR THE DETERMINATION OF ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE BY RP-HPLC

A simultaneous stability-indicating reversed-phase high performance liquid chromatography (HPLC) method for analysis of abacavir (ABC), dolutegravir (DTG) and lamivudine (3TC) as the bulk drug and in the formulation was developed. Compounds were separated on Kinetex 5 µ C18 100 A (250 mm x 4.6 mm). A gradient program of mobile phase at different proportions of acetonitrile (ACN) and water was used. The retention times of ABC, DTG and 3TC were 5.2, 8.4 and 3.1 minutes (mins) respectively. The drugs were subjected to the stress conditions of acid, base, oxidative, hydrolytic, humidity, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating ability of the method. The method was linear in the concentration range of 20–100 μg/mL, 2-16μg/mL and 10-80 μg/mL for ABC, DTG and 3TC respectively. The method was accurate and precise with a limit of detection and limit of quantitation of 2.05 and 6.73 µg/ mL, 0.28 and 0.94 µg/ mL and 2.32 and 7.72 µg/ mL for ABC, DTG and 3TC respectively. The method was applied for the analysis of ABC, DTG and 3TC in the presence of its degradation products and commonly used excipients and was found to be specific. The developed method is stability indicating, precise and specific which can be applied for the routine analysis.