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

For analysis of lamivudine (LAMI), abacavir (ABA), dolutegravir (DOLU) in the bulk drug and in the formulation was developed. Compounds were separated on Inersil ODS (4.6 × 250 mm x 5 mm). A gradient program of mobile phase at different proportions of Phosphate Buffer pH-7 & Acetonitrile was used. The retention times of LAMI, ABA & DOLU were 2.555, 4.282, 7.101 minutes (mins.) respectively. The drugs were subjected to the stress conditions of acid, base, oxidative & thermal 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 0– 150μg/mL, 0-300 μg/mL and 0-25 μg/mL for LAMI, ABA & DOLU respectively. The method was accurate and precise with a limit of detection and limit of quantitation of 0.31 and 0.94 µg/ mL, 0.21 and 0.65 µg/ mL and 0.48 and 1.46 µg/ mL for LAMI, ABA & DOLU respectively. The method was applied for the analysis of LAMI, ABA & DOLU 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. Key words: Lamivudine, Abacavir, Dolutegravi and stability-indicating